#Food Safety Testing Market Reports

[ananya5400]

The global food safety testing in nutrigenomics and personalized nutrition market is poised for substantial growth, with its value expected to rise from USD XX.X billion in 2024 to USD XX.X billion by 2029, reflecting an impressive CAGR of X.X%.

[supriyab]

The food pathogen safety testing equipment and supplies market is estimated to be valued at USD 7.4 billion in 2023 and is projected to reach USD 10.4 billion by 2028, at a CAGR of 7.1% from 2023 to 2028.

[foodagriculturenews]

The food pathogen testing market size is predicted to grow at a CAGR of 8.4% between 2023 and 2028, reaching a value of $22.7 billion by 2028 from a projection of $15.1 billion in 2023.

[thoughtportal]

When Simon Bogemann’s hand began cramping around the steering wheel in a claw position on his commute from Geelong to Melbourne, he began to worry.

Bogemann, then 43, was also getting pins and needles in his feet and fingers every night in bed, and while sitting down during short lunch breaks at work.

His GP put it down to a lack of magnesium and recommended a supplement, in addition to the multivitamin he was taking for a chronic condition.

Bogemann was unaware that both capsules contained added vitamin B6, too much of which could lead to the symptoms he was experiencing – a type of nerve damage known as peripheral neuropathy.

The wellness industry’s marketing of over-the-counter vitamins is leading to an increase in the number of people presenting with peripheral neuropathy linked to excessive vitamin B6 in their blood, Australia’s peak body for pathologists has warned.

Dr David Kanowski, a chemical pathologist at Sullivan Nicolaides Pathology in Brisbane, says most people are unaware they are consuming too much of the vitamin.

Bogemann certainly had no idea: “You buy an over-the-counter supplement, you just think that it’s going to be good for you, not bad for you.”

He says it has been a challenge to change his multivitamin to a product without B6.

“One thing that I have learned is that B6 seems to be added, for some reason, to a lot of over-the-counter supplements.”

It is also in some energy drinks, breakfast cereals, and protein and weight loss shakes.

Magnesium tablets, commonly recommended for cramp relief, often contain B6 because it can assist magnesium absorption. But a person who takes two magnesium tablets a day could consume more than 120mg of B6, far exceeding the recommended dietary intake for adults in Australia of 1.3mg to 2mg a day.

It was previously believed that peripheral neuropathy was caused by doses of hundreds of milligrams taken over periods of 12 months or more but cases have been known to occur at levels as low as 21mg.

The initial symptoms include numbness and pins and needles in the feet, which can spread up the legs. Muscle cramps and pain may be felt in the arms and hands.

In 2020 the Therapeutic Goods Administration released a safety advisory warning. Two years later, still concerned about a lack of awareness, the TGA lowered the limit at which products must display a warning label, from 50mg of B6 down to 10mg – and banned products with more than 100mg.skip past newsletter promotion

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Nevertheless, cases have continued to rise. Between January 2020 and October 2024 the TGA received 81 adverse event reports of peripheral neuropathy associated with medicines containing a vitamin B6 ingredient, with most of them reported in the past two years.

Kanowski says advertising on social and other media promotes the idea that taking more vitamins is good for health.

“It’s understood that if you want to counteract bad habits, like smoking or drinking too much, perhaps that can be counterbalanced with vitamins,” he says.

Kanowski says the TGA has been “fairly hands off” unless toxins are in a product.

Fiona Sammut, a dietitian based in Victoria, says it’s a big ask to expect consumers to read and interpret “tiny font” disclaimers and formulations.

People who see claims that vitamins will “boost their energy” may take several supplements thinking they are harmless, she says.

While foods are commonly fortified with vitamins for “specific evidence-based reasons”, such as vitamin B1 fortified bread, Sammut says there’s no similar reason for B6 fortification because there isn’t a high incidence of vitamin B6 deficiency.

Most people get enough B6 in their diets from foods including fish, non-citrus fruits and starchy vegetables, and high intakes of B6 from natural food sources have not been reported to cause adverse effects.

Sarah* had symptoms of peripheral neuropathy for years, but “never thought anything of it”, because she assumed they were related to her Crohn’s disease.

In hindsight, she says, the symptoms began about a year after she began taking a multivitamin that contained 60mg of B6 after weight loss surgery in 2011, in addition to the magnesium which contained 82mg she had been taking for years due to cramps in her legs.

She had been having yearly blood tests at her dietician’s recommendations but it was only in late 2021 that the pathology lab tested for B6 levels and found they were 15 times higher than the recommended range.

In most cases, once B6 levels return to normal, peripheral neuropathy will slowly improve within six to 12 months but in some severe cases it can be irreversible.

Prof Matthew Kiernan, the chief executive of Neuroscience Australia, has described a case he saw in his clinical practice of a 40-year-old patient who was worried he had motor neurone disease before the doctor linked the gym enthusiast’s symptoms to excessive vitamin B6 intake from the supplements he consumed as part of his fitness program.

Kiernan, who diagnosed more patients with peripheral neuropathy after his article on the case was published in the Medical Journal of Australia, believes there should be limits on the number of supplements people can buy because they are unnecessary for people eating a balanced diet.

“None of this is policed,” he says. “So, if you go down to the chemist and go down the vitamin aisle, they’re all there. You can get a whole shopping trolley full of them.”

[mariacallous]

"I’m going to let him go wild on health,” former president Donald Trump said of Robert F. Kennedy Jr. at his Madison Square Garden rally in New York City this past weekend. “I’m going to let him go wild on the food. I’m going to let him go wild on the medicines.”

Kennedy, a former Democrat, suspended his presidential campaign in August and endorsed Trump. He has since launched the Make America Healthy Again campaign, an initiative focused on tackling chronic diseases that Trump has seemingly embraced in recent weeks. Given Kennedy’s anti-vaccination stance and conspiratorial leanings, some policy experts and former government officials are concerned about how his views could shape the nation’s health agenda.

Kennedy has long made false statements about the safety of vaccines and has touted disproven treatments for Covid-19, including ivermectin and hydroxychloroquine. On the campaign trail, he has railed against seed oils, blaming several chronic health conditions on their presence in processed foods.

How much influence Kennedy could have on national health policy will all depend on his role within a future Trump administration. Trump did not clarify his remarks at Sunday’s event, including what position he is considering Kennedy for. According to a CNN report that ran late Tuesday, Kennedy said Trump ���promised him control of the public health agencies,” but in an email to WIRED on Wednesday, Steven Cheung, Trump’s campaign communications director, said that formal discussions of who will serve in a second Trump administration are premature.

Trump could be considering Kennedy to lead the Department of Health and Human Services, which has 80,000 federal employees, or one of the agencies within it, such as the Food and Drug Administration or the Centers for Disease Control and Prevention. It would be a departure from his previous top health picks, who had lengthy government or public health careers. For instance, Alex Azar, Trump’s HHS secretary, was deputy HHS secretary under George W. Bush and an executive at drugmaker Eli Lilly. Scott Gottlieb, a physician and investor appointed as FDA commissioner under Trump, had previously worked for the FDA and had served on the boards of pharma and biotech companies.

When asked to elaborate on Kennedy’s health priorities, Amaryllis Fox Kennedy, the former candidate’s campaign director and daughter-in-law, told WIRED: “Bobby aims to end conflicts and corruption at the agencies, ensure all testing is undertaken by scientists who have no financial interest in the outcome, and all results of all trials are released to the public. The free market will take care of it from there.” (The National Institutes of Health already requires results of clinical trials funded by the agency to be published to a government database.)

Jerome Adams, US surgeon general under Trump and current executive director of health equity initiatives at Purdue University, says that even if Kennedy were tapped to lead HHS, the FDA, or the CDC, it’s unlikely that he would ascend to one of those roles due to his lack of medical training and controversial views on public health issues. “Congressional approval is required for these positions, and his stances could be a barrier,” Adams says.

If Republicans control the Senate after next week’s election, though, that calculus could change. “The GOP has generally fallen into line in terms of supporting candidates that President Trump does,” says Genevieve Kanter, associate professor of public policy at the University of Southern California.

If chosen to be FDA commissioner, Kennedy would control the agency’s budget and priorities and could have a sizable impact by installing lower-level appointees who are sympathetic to his worldview. While the FDA commissioner does not single-handedly approve or authorize new drugs, Kantner says outside political pressure can certainly influence that process. Kennedy could also appoint members to FDA advisory committees, panels of outside experts that make recommendations to the agency on drug approvals and other regulatory matters. The FDA often follows the recommendations of advisory committees when making decisions on new drug approvals, but not always.

The FDA can also choose to not enforce some rules in certain circumstances—what’s known as enforcement discretion. Given his support for dubious and unproven therapies, such as stem cells and hyperbaric oxygen, an FDA under Kennedy, for instance, could choose to not go after companies that market unapproved treatments.

“When we think of the kind of person we want to be head of HHS or be FDA commissioner, someone ‘going wild’ isn’t exactly the first trait that comes to mind,” Kanter says. “It wouldn’t ease the public’s concern that we would see more food safety incidents and adverse events from poorly regulated drugs and devices from a lax administration that is known for embracing unscientific theories.”

Kennedy wouldn’t have free rein though. Existing laws and regulations govern how the agency works, and a new FDA commissioner wouldn’t be able to get rid of those quickly. “If you’re dealing with regulatory issues that have been long-standing and have lots of precedent, it’s just not possible to turn some of those things around or dismiss them overnight,” says a past leader of the FDA, who requested anonymity so that they could speak freely.

Likewise, even in a leadership role at HHS or the CDC, Kennedy wouldn’t be able to easily affect vaccine policy. Vaccine recommendations are made by the Advisory Committee on Immunization Practices, which comprises outside medical and public health experts. Georges Benjamin, executive director of the American Public Health Association, says Kennedy could try to stack that advisory committee with people who are sympathetic to his views on vaccination, but those members are chosen through a rigorous nomination process.

“He could certainly change policy that way, but it takes a while and it won't be a secret. There are ways in which the public can push back, including taking a case to court,” he says.

Kennendy could have influence in other ways beyond direct control of a public health agency. Trump could potentially bring Kennedy on as a White House adviser, which wouldn’t require approval by the Senate.

“Without congressional vetting and oversight, there is potential for unchecked impact. RFK's views could shape health policies, raising concerns about misinformation and harm,” Adams says.

Karoline Leavitt, national press secretary for the Trump campaign, told WIRED in an email that if reelected, Trump will establish a “special Presidential Commission of independent minds and will charge them with investigating what is causing the decades-long increase in chronic illnesses.” She did not say whether Kennedy would be chosen for that task force.

Kennedy has also been sizing himself up for another position in a potential Trump cabinet: agriculture secretary. A longtime environmental activist, Kennedy has promised to take on big farms and feedlots, reduce pesticides, and fix what he presents as a food system captured by corporate interests. “When Donald Trump gets me inside,” Kennedy said in a video shot outside the Department of Agriculture headquarters in Washington, DC, “it won’t be that way any more.”

This platform is a continuation of Kennedy’s long history as an antagonist against the agriculture industry. In 2018, Kennedy and a team of attorneys won an initial $289 million settlement against Monsanto, representing a groundskeeper who developed cancer after being soaked with a herbicide made by the agrochemical firm. He also attempted to sue the pig farming company Smithfield because of its production of hog manure, although that case was thrown out by a federal judge.

Kennedy’s past makes him an unlikely candidate for agriculture secretary, according to Daniel Glickman, who served in the role during Bill Clinton’s presidency. “It’s hard for me to imagine, given Trump’s traditional base in the heartlands, that he would pick somebody who was an advocate for breaking up large farms and breaking consolidated agriculture,” says Glickman.

Like top posts at HHS, the USDA secretary position would need to be confirmed by a Senate vote. “I don’t think [Kennedy] is a slam dunk,” says Glickman.

Trump’s pick for USDA chief during his first term was Sonny Perdue, a former governor of Georgia and founder of an agricultural trading company. Most agriculture secretaries either have a background in the industry or politics—two crucial constituencies for the person who will be in charge of a department that employs nearly 100,000 and is made up of 29 agencies, including forestry, conservation, and nutrition programs. “The difference between Sonny Perdue and Robert F. Kennedy, Jr. is like night and day,” says Glickman.

If Kennedy were to be confirmed as agriculture secretary, he might struggle to enact the most radical parts of his program. He is an outspoken critic of pesticides, but the USDA is generally not in charge of regulating those, says Dan Blaustein-Rejto, director of agriculture policy and research at the Breakthrough Institute. Rather, the EPA regulates pesticides with public health uses.

Although he may not be able to directly influence pesticide regulations, Kennedy has said he would try to “weaponize” other agencies against “chemical agriculture” by commissioning scientific research into the effects of pesticides. The USDA Agricultural Research Service has a nearly $2 billion discretionary budget for research into crops, livestocks, nutrition, food safety, and natural resources conservation.

There are other levers that an agriculture secretary could pull, says Blaustein-Rejto. The USDA is investing $3 billion through the partnership for climate-smart commodities—a scheme that’s supposed to make US agriculture more climate-friendly. A USDA chief might be able to put their thumb on their scale by influencing the selection criteria for these kinds of programs. The USDA also oversees the Commodity Credit Corporation (CCC), which has a $5 billion fund that it uses to support farm incomes and conservation programs, and to assist farmers hit by natural disasters. It’s possible that a USDA chief could influence how these CCC funds are distributed by the agency.

Kennedy has also argued that corporate interests have captured the US’s dietary guidelines, and he pledged to remove conflicts of interest from USDA groups that come up with dietary guidelines. US dietary guidelines are developed jointly by the USDA and HHS and are updated every five years, giving the agriculture secretary limited opportunities to influence any recommendations.

“If RFK is in a high-level policy role, I expect to see a lot more talk about ultra-processed foods, but I’m not sure what that would actually entail when it comes to the dietary guidelines,” says Blaustein-Rejto.

The experts WIRED spoke with largely think Kennedy’s more extreme positions will likely be constrained by bureaucracy. But the message that elevating a vocal vaccine skeptic and conspiracy theorist would send remains a serious concern ahead of a potential second Trump administration.

[killed-by-choice]

“Sadie Roe,” 24 (USA 2013)

“Sadie” died after undergoing a chemical abortion. Her death was counted in the FDA Adverse Event Summary for the mifepristone/misoprostol abortion regimen, but despite investigation, it is still unknown which of her complications caused her death.

Sadie was 24 and had no known health problems. On or about August 15, 2013, she underwent the abortion. She began to feel sick afterwards and went to a doctor, who prescribed an antibiotic. It is unknown what kind of infection the doctor had diagnosed.

On August 20, someone found Sadie’s dead body. An autopsy was conducted to try to find out how a young woman went from healthy to dead in five days.

The autopsy results came back with a mystery. Although traces of cannabinoids and ibuprofen (most likely Sadie’s attempt to treat her pain) were detected, both were so inconsequential that the toxicology report cleared her as negative. Neither drug was in a concentration that could have killed her. Many people had already died of sepsis caused by Clostridium bacteria, so tissue samples were sent to the CDC for testing. The samples came back negative for the species tested.

However, several life-threatening problems were found at Sadie’s autopsy. She had retained part of the placenta from the abortion, which is a serious complication that risks infection. Her organs were damaged; she suffered “acute visceral and pulmonary congestion and edema.” Microbiology testing had come back negative for the Clostridium strain that had been investigated, but after less than a day the cultures grew streptococcus viridans.

So which of these killed Sadie? The coroner initially listed “unspecified natural causes,” but the CDC analyzed her case and tried to determine what the cause of death was. They finally concluded that the cause of death was undetermined, but included her in the count of pregnant people who died after chemical abortion.

Years later, six doctors reviewed Sadie’s case. They found the confirmation of retained placenta, her symptoms and the Streptococcal species in her lab cultures to be indicative of sepsis and Acute Respiratory Distress Syndrome. Viridans group streptococci can cause life-threatening infections and had been reported to have antibiotic-resistant strains, so this is also consistent with the Azithromycin prescription.

While we still do not have a definite answer on the precise cause of Sadie’s death (and sadly, we may never be sure), it can be assumed beyond reasonable doubt that side effects of the abortion played a highly significant role.

Individual Case Safety Report number 9587011-03-00-01, Danco Laboratories, LLC. Office of Post-marketing Drug Risk Assessment, Food and Drug Administration.

https://www.fda.gov/media/154941/download

[meret118]

Tainted CPAP machines and ventilators went to children, the elderly and at least 700,000 veterans despite internal warnings. Company insiders said the devices posed an “unacceptable” risk.

The first complaints landed at the offices of Philips Respironics in 2010, soon after the company made a fateful decision to redesign its bestselling breathing machines used in homes and hospitals around the world.To silence the irritating rattle that kept users awake at night, Philips packed the devices with an industrial foam — the same kind used in sofas and mattresses. It quickly became clear that something had gone terribly wrong.

The reports coming into Philips described “black particles” or “dirt and dust” inside machines that pump air to those who struggle to breathe. One noted an “oily-like” substance. Others simply warned of “contamination.”

Yet Philips withheld the vast majority of the warnings from the Food and Drug Administration, even as their numbers grew from dozens to hundreds to thousands and became more alarming each year.

. . .

Instead, as the complaints continued to pile up in company files, Philips waged aggressive global marketing campaigns to sell more machines, including new models fitted with the hazardous foam.The sales pitch worked: The devices went to infants, the elderly and at least 700,000 veterans. The company also promoted machines meant for some of the sickest people in the country, rolling out a new ventilator filled with the foam in the early months of the COVID-19 pandemic.

. . .

All the while, people using Philips machines were suffering from illnesses that no one could explain: vomiting, dizziness and headaches, along with newly diagnosed cancers of the lungs, throat, sinuses and esophagus. One man in Philadelphia coughed so hard that he broke his ribs, and a Florida woman with a hacking cough was hospitalized for days and placed on oxygen.

. . .

Studies published in scholarly journals showed the foam broke apart in heat and moisture. The company used it anyway, even though the machines send air for hours at a time into the lungs of users.

. . .

As news of the problem spread, customers and others stepped forward by the thousands, describing emergency room visits and sudden illnesses in reports submitted to Philips and the government. The reports detailed nearly 2,000 cases of cancer, 600 liver and kidney illnesses and 17,000 respiratory ailments.

. . .

The company acknowledges that the foam tested positive for genotoxicity — its own experts described “uncontrolled cellular replication” — but said that a third-party assessment still concluded the machines are unlikely to cause harm.

The three experts consulted by the news organizations said that’s not possible. While safety thresholds for chemical emissions vary and findings can be open to interpretation, genotoxicity means that one or more chemicals are changing cells, the building blocks of the human body.

“You can’t make the argument that it’s safe. That’s bad science,” said the engineer familiar with the Philips testing. “It’s a real-life failure that shows you have a problem. There’s no ambiguity. There is unacceptable risk. Full stop.”

The company’s ventilators also tested positive for genotoxicity; Philips said the devices are still being assessed.

. . .

More details about the health risks are expected to emerge through the ongoing federal lawsuits in Pittsburgh. Earlier this month, the company reached a settlement in one of the cases, agreeing to pay at least $479 million to reimburse customers and others for the costs of the defective machines.

Other legal challenges are still ongoing, including more than 600 personal injury claims and a class-action suit seeking ongoing medical monitoring and research on the dangers posed by the devices.

------

They knew the foam would break down when they decided to use it. Tests within the company after complaints came in showed how dangerous the devices were, but they refused to even change the design for new sales, much less recall the old ones. For every official complaint, how many more people were harmed that weren't reported?

They didn't recall them until 3,700 official complaints had been made. Until after they sold over 5 million life-threatening machines. There's no way to know how many people they killed.

If they think the products are so great, then they won't mind being forced to use them.

Companies will keep doing this until the financial cost of hurting people is greater than the profits from doing so.

Trigger warning for disturbing medical details, descriptions of suffering, and an image of a permanent feeding tube, in the article.

[spooniestrong]

Why you should avoid kava and 9 other risky dietary supplements

One-third of Americans say they believe supplements have been tested by the Food and Drug Administration for safety, according to a 2022 nationally representative survey by Consumer Reports of 3,070 adults in the United States. But the FDA doesn’t approve or test the safety or effectiveness of any supplement before it enters the U.S. market.

After consulting with a panel of doctors and researchers, Consumer Reports says you should avoid these 10 risky supplements. In general, risk increases the larger the dosage and the longer the supplement is taken. Also beware of illegal or unapproved drug ingredients, such as tianeptine, methylsynephrine and phenibut.

Chaparral

Also called: creosote bush, greasewood, Larrea divaricata, Larrea tridentata, larreastat

Claimed benefits: weight loss; eases inflammation; treats colds, infections, rashes, cancers

Potential harms: kidney problems, liver damage

Coltsfoot

Also called: coughwort, Farfarae folium leaf, foalswort, Tussilago farfara

Claimed benefits: relieves cough, sore throat, laryngitis, bronchitis, asthma

Potential harms: liver damage, possible carcinogen

Comfrey

Also called: blackwort, bruisewort, slippery root, Symphytum officinale

Claimed benefits: relieves cough, heavy menstrual periods, stomach problems, chest pain; treats cancer

Potential harms: liver damage, cancer

Germander

Also called: Teucrium chamaedrys, Teucrium viscidum

Claimed benefits: weight loss; alleviates fever, arthritis, gout, stomach problems

Potential harms: liver damage, hepatitis

Greater celandine

Also called: celandine, Chelidonium majus

Claimed benefits: alleviates stomach ache

Potential harms: liver damage

Kava

Also called: ava pepper, kava kava, Piper methysticum

Claimed benefits: eases anxiety, helps sleep

Potential harms: liver damage, exacerbates Parkinson’s disease and depression, impairs driving

Lobelia

Also called: asthma weed, Lobelia inflata, vomit wort, wild tobacco

Claimed benefits: helps respiratory problems, smoking cessation

Potential harms: nausea, vomiting, diarrhea, tremors, rapid heartbeat, confusion, seizures, hypothermia, coma

Pennyroyal oil

Also called: Hedeoma pulegioides, Mentha pulegium

Claimed benefits: improves breathing problems, digestive disorders

Potential harms: liver and kidney failure, nerve damage, convulsions

Usnic acid

Also called: beard moss, tree moss, usnea

Claimed benefits: weight loss, pain relief

Potential harms: liver injury

Yohimbe

Also called: Johimbi, Pausinystalia yohimbe, yohimbine, Corynanthe johimbi

Claimed benefits: treats low libido and erectile dysfunction, depression, obesity

Potential harms: raises blood pressure; causes rapid heart rate, headaches, seizures, liver and kidney problems, heart problems, panic attacks

Source: Consumer Reports Inc.

Consumer Reports is an independent, nonprofit organization that works side by side with consumers to create a fairer, safer, and healthier world. CR does not endorse products or services, and does not accept advertising. Read more at ConsumerReports.org.

[prxengage14]

Empowering Startups: Equipment Financing Solutions in Texas, Hawaii, and NYC

Understanding Clinical Trial Registries are at the heart of medical innovation, offering a systematic way to test new treatments, therapies, and drugs for safety and efficacy. In Canada, clinical trial registries and proper management of trials are essential to ensuring transparency, safety, and ethical standards. This article explores the importance of clinical trial registries, the role of investigational drug studies, and managing adverse events in clinical research.

What Are Clinical Trial Registries?

A clinical trial registry is a publicly accessible database where information about ongoing and completed clinical trials is recorded. These registries serve as a valuable resource for researchers, healthcare professionals, and the general public. In Canada, the Health Canada Clinical Trial Registry Database (HCCTD) is a key registry that tracks trials approved by Health Canada.

Registries ensure transparency in clinical research by documenting the purpose, methodology, and outcomes of trials. This helps prevent duplication, promotes accountability, and allows participants and stakeholders to make informed decisions. Additionally, the International Clinical Trials Registry Platform (ICTRP), managed by the World Health Organization (WHO), provides a global framework for harmonizing clinical trial registries, including those in Canada.

The Importance of Investigational Drug Studies

Investigational drug studies focus on testing new drugs or combinations of drugs to evaluate their safety and efficacy. These studies are conducted in phases:

Phase 1: Focuses on safety and dosage, typically involving a small number of healthy volunteers.

Phase 2: Tests the drug's efficacy on a larger group with the target condition while continuing to assess safety.

Phase 3: Involves even larger populations to confirm efficacy, monitor side effects, and compare the drug to existing treatments.

Phase 4: Conducted after market approval to gather additional data on long-term safety and effectiveness.

Canada follows strict guidelines under the Food and Drugs Act and associated regulations to ensure that investigational drugs undergo rigorous testing before approval. Ethics committees and institutional review boards (IRBs) oversee these studies to protect the rights and safety of participants.

Managing Adverse Events in Clinical Trials

Managing clinical trial adverse events Adverse events (AEs) are unintended effects that occur during clinical trials, ranging from mild side effects to serious medical complications. Proper management of AEs is critical to ensuring participant safety and maintaining the integrity of the trial.

Researchers in Canada are required to report serious adverse events (SAEs) to Health Canada and the trial's ethics board within a stipulated timeframe. Managing AEs involves:

Monitoring and documentation: Accurate recording of AEs to assess their frequency and severity.

Risk mitigation: Adjusting dosages, altering protocols, or pausing trials to address safety concerns.

Participant communication: Ensuring participants are informed about potential risks and updates during the trial.

Conclusion

Clinical trial registries, investigational drug studies, and adverse event management form the backbone of ethical and effective medical research. By leveraging tools like the Health Canada Clinical Trials Database and adhering to stringent safety protocols, Canada continues to lead in advancing healthcare innovation. For researchers, participants, and healthcare providers, Understanding investigational drug studies these processes is essential to fostering trust and progress in clinical research.

[corporatemitra]

Drug Licensing: Navigating the Path to Market with Corporate Mitra

The pharmaceutical industry plays a crucial role in global healthcare, driving innovation and delivering life-saving medications. However, before a drug reaches the market, it must undergo a rigorous licensing process to ensure safety, efficacy, and quality. This process, known as drug licensing, involves multiple stages, regulatory bodies, and extensive documentation. Navigating this complex pathway can be challenging for pharmaceutical companies, particularly small and medium-sized enterprises (SMEs). This is where Corporate Mitra steps in, offering end-to-end support in drug licensing and regulatory compliance.

What is Drug Licensing?

Drug licensing refers to the authorization granted by regulatory authorities, allowing pharmaceutical products to be marketed and sold within a particular region or country. This process ensures that drugs meet established safety and efficacy standards, safeguarding public health. Licensing involves pre-clinical and clinical trials, dossier preparation, regulatory submissions, and post-marketing surveillance.

Key regulatory bodies overseeing drug licensing include:

U.S. Food and Drug Administration (FDA) – United States

European Medicines Agency (EMA) – European Union

Medicines and Healthcare Products Regulatory Agency (MHRA) – United Kingdom

Central Drugs Standard Control Organization (CDSCO) – India

Therapeutic Goods Administration (TGA) – Australia

The Drug Licensing Process: A Step-by-Step Guide

1. Preclinical Development

Before a drug can be tested in humans, it undergoes preclinical development. This stage involves laboratory research and animal testing to assess pharmacodynamics, pharmacokinetics, and toxicity.

Key Activities:

Compound synthesis and characterization

In vitro (test tube) and in vivo (animal) studies

Safety and toxicity profiling

Outcome:

Identification of lead compounds

Determination of safe dosage ranges

2. Clinical Trials

Clinical trials are conducted in three phases to test the drug in humans.

Phase I: Tests safety and dosage in a small group of healthy volunteers.

Phase II: Evaluates efficacy and side effects in a larger patient group.

Phase III: Confirms effectiveness, monitors adverse reactions, and compares the drug to existing treatments in a large patient population.

Outcome:

Collection of comprehensive data on safety, efficacy, and quality.

3. Regulatory Submission and Approval

Following successful clinical trials, pharmaceutical companies compile all findings into a dossier for submission to regulatory authorities. This dossier typically includes:

Clinical trial data

Manufacturing processes

Quality control measures

Proposed labeling and packaging

Regulators review the submission, request additional data if necessary, and, if satisfied, grant marketing authorization.

Outcome:

Approval to market and distribute the drug

4. Post-Marketing Surveillance (Phase IV)

Even after a drug is licensed, ongoing surveillance is essential to detect rare or long-term side effects. This phase includes:

Adverse event reporting

Periodic safety update reports (PSURs)

Post-marketing studies

Challenges in Drug Licensing

Drug licensing is fraught with challenges that can delay market entry and increase costs. Common obstacles include:

Regulatory Variations: Different countries have varying regulatory requirements, necessitating customized submissions.

Complex Documentation: Preparing comprehensive and error-free dossiers requires expertise.

Lengthy Timelines: The process can take several years, particularly for innovative drugs.

Cost Implications: Clinical trials and licensing procedures are expensive.

How Corporate Mitra Facilitates Drug Licensing

Corporate Mitra is a leading consultancy specializing in regulatory affairs, offering tailored solutions to streamline drug licensing. Their services cover the entire lifecycle of drug development, ensuring timely and efficient market entry.

1. Regulatory Strategy and Consultation

Corporate Mitra develops robust regulatory strategies, aligning with the specific requirements of target markets. Their experts provide guidance on clinical trial design, regulatory submissions, and dossier preparation.

Benefits:

Faster approval timelines

Minimized risk of regulatory rejection

2. Dossier Preparation and Submission

Corporate Mitra’s team of regulatory professionals ensures meticulous preparation of submission dossiers. They compile data, validate documents, and liaise with regulatory authorities to address queries promptly.

Benefits:

High-quality submissions

Reduced errors and resubmissions

3. Clinical Trial Management

Corporate Mitra offers end-to-end clinical trial management, from protocol design to trial execution and data analysis. They ensure compliance with Good Clinical Practice (GCP) standards.

Benefits:

Efficient trial execution

Comprehensive data collection

4. Post-Marketing Support

Corporate Mitra continues to support pharmaceutical companies even after product launch. Their services include pharmacovigilance, PSUR preparation, and risk management planning.

Benefits:

Ongoing regulatory compliance

Enhanced product safety monitoring

Case Study: Successful Drug Licensing with Corporate Mitra

Client: A mid-sized pharmaceutical company Challenge: The company faced difficulties in navigating regulatory requirements for a new oncology drug. Solution: Corporate Mitra provided comprehensive support, including regulatory strategy development, clinical trial oversight, and dossier preparation. Outcome: The drug received FDA approval within 12 months of submission, significantly faster than industry norms.

Conclusion

Drug licensing is a critical but challenging process that demands expertise, precision, and strategic planning. Corporate Mitra emerges as a trusted partner, guiding pharmaceutical companies through every stage of licensing, from preclinical development to post-marketing surveillance. By leveraging Corporate Mitra’s services, companies can achieve faster market entry, regulatory compliance, and ultimately, improved patient outcomes.

For pharmaceutical firms seeking to navigate the complexities of drug licensing, Corporate Mitra offers the expertise and support necessary to succeed in today’s competitive landscape.

[ananya5400]

The food pathogen safety testing equipment and supplies market is experiencing significant global growth due to growing concerns about food safety and its impact on consumer health. Stricter regulations and high-profile foodborne illness outbreaks have increased public awareness, driving the demand for advanced testing solutions.

[aravalihoneyindustries]

"The Role of Bulk Honey Suppliers in the Global Honey Market"

The honey industry in India is one of the fastest-growing sectors in the food and agricultural markets, driven by increasing consumer demand for natural and organic products, as well as the rise of health-conscious eating habits. Among the key players in this thriving market are bulk honey suppliers, who play a pivotal role in the supply chain by sourcing, processing, and distributing honey in large quantities to businesses, retailers, and consumers. This article delves into the significant role that bulk honey suppliers play in the Indian honey market, exploring their impact on quality, pricing, distribution, and the overall growth of the sector natural honey suppliers.

Understanding Bulk Honey Suppliers Bulk honey suppliers are companies or entities that purchase raw honey in large quantities directly from beekeepers or honey producers and then supply it to manufacturers, wholesalers, retailers, and even large-scale consumers like food processing companies. These suppliers act as intermediaries between honey producers (typically small or medium-scale beekeepers) and the end users, ensuring that honey is available in bulk and at affordable prices.

In India, where honey consumption has been rising steadily, bulk honey suppliers are crucial for ensuring a steady supply of honey to meet both domestic demand and the growing export market. The suppliers not only ensure the honey’s availability across different regions but also play a key role in maintaining quality and consistency, which is critical in a market that is as diverse and vast as India.

The Growing Demand for Honey in India India is one of the largest producers and consumers of honey in the world. According to various reports, the demand for honey has been increasing steadily due to growing awareness of its health benefits, its use in traditional medicine, and its role as a natural sweetener. Factors like the increase in the number of people adopting healthier lifestyles, the preference for organic food, and the widespread use of honey in Ayurveda have also contributed to this surge.

The growing demand for honey in India is met not only by domestic production but also by imports from countries like China, Vietnam, and Ukraine. However, with the demand for high-quality honey on the rise, the importance of local bulk honey suppliers in ensuring quality control, traceability, and supply chain transparency is becoming more apparent.

The Role of Bulk Honey Suppliers in Quality Control One of the most critical roles that bulk honey suppliers play in the Indian market is maintaining the quality of honey. Honey’s quality can vary significantly depending on the region, the plants the bees pollinate, and the methods used for extraction and processing. Consumers are becoming increasingly aware of the importance of raw, unfiltered, and organic honey, which is why bulk honey suppliers must implement stringent quality control measures.

Sourcing Honey from Trusted Beekeepers: Bulk honey suppliers often work closely with beekeepers to source high-quality raw honey. By establishing relationships with trusted and certified beekeepers, suppliers ensure that the honey meets specific standards, such as organic certification or compliance with food safety regulations. These relationships are crucial to building a reliable supply chain that consistently delivers high-quality honey.

Ensuring Purity: One of the most important aspects of honey quality is purity. Honey can sometimes be adulterated with sugar, corn syrup, or other substances, which can affect its taste and health benefits. Bulk honey suppliers use advanced testing methods to ensure the purity of honey before it is distributed to retailers or food manufacturers. By performing regular quality checks, suppliers ensure that consumers are receiving unadulterated, natural honey.

Maintaining Consistency: Another challenge for honey suppliers is maintaining consistency in terms of taste, color, and viscosity. Since honey is a natural product that is influenced by seasonal variations and the specific flora available for pollination, suppliers need to blend different batches to ensure that the final product meets the required standards. This process is especially important for large-scale manufacturers who need consistent honey for their products, whether it be packaged honey jars or honey-based food ingredients.

Pricing and Cost Factors in Bulk Honey Supply Bulk honey suppliers are integral to determining the price structure of honey in the Indian market. The price of honey can fluctuate based on a variety of factors, including:

Supply and Demand: The demand for honey often exceeds local supply, especially during the off-season, which can drive up prices. Bulk honey suppliers have to manage their inventories effectively to ensure there is enough stock to meet demand while avoiding price volatility.

Beekeeping Costs: Beekeeping, which includes maintaining hives, ensuring the health of the bees, and managing the harvesting process, can be a costly endeavor. Bulk honey suppliers often purchase honey directly from beekeepers at rates that allow the beekeepers to maintain a sustainable livelihood while keeping prices reasonable for consumers.

Import Prices: Since India also imports honey, especially to meet the demand for varieties like Manuka or premium-grade honey, the pricing of imported honey can significantly affect the overall market. Bulk honey suppliers are responsible for negotiating prices with both domestic and international suppliers to ensure competitive pricing for their clients.

Packaging and Distribution Costs: Bulk honey suppliers are also responsible for packaging and distribution to retail outlets and food manufacturers. The costs associated with packaging, labeling, and logistics can affect the final price of honey. Suppliers work to optimize these costs while ensuring that the honey reaches its destination safely and in the best condition possible.

The Impact of Bulk Honey Suppliers on Distribution Networks Bulk honey suppliers are central to ensuring that honey is widely available to consumers across India. Their role in the distribution network extends beyond simply supplying honey in bulk quantities to include logistics, inventory management, and ensuring timely delivery to retailers and other clients.

Widespread Availability: Bulk suppliers play an essential role in making honey available in both urban and rural markets. As a result, even small-scale retail outlets can stock honey, ensuring that consumers in remote areas have access to high-quality honey products.

Wholesale Markets: In India, where a vast number of honey transactions occur in wholesale markets, bulk honey suppliers play a crucial role in ensuring honey is readily available for both small and large-scale retailers. By ensuring steady distribution channels, they keep honey prices competitive and help maintain product availability throughout the country.

Export Opportunities: India is also a significant exporter of honey, and bulk honey suppliers are crucial to the export process. They work to source high-quality honey that meets international standards and supply it to foreign markets, capitalizing on the growing global demand for Indian honey, especially varieties such as Acacia and Mustard honey.

The Future of Bulk Honey Suppliers in India The role of bulk honey suppliers in the Indian honey market will continue to evolve as consumer demand for high-quality, organic, and ethically sourced honey increases. With the rise of health-conscious consumers and a growing preference for sustainable products, bulk honey suppliers will need to innovate and adapt to meet these changing demands.

Technology will play a significant role in the future of honey supply chains. Bulk honey suppliers can leverage data analytics and tracking systems to ensure transparency in sourcing, improve inventory management, and enhance traceability. Additionally, with the rise of e-commerce, bulk honey suppliers will increasingly be tasked with providing direct-to-consumer solutions, opening up new avenues for growth.

Conclusion Bulk honey suppliers are integral to the Indian honey market, bridging the gap between honey producers and consumers. They ensure that honey is consistently available, maintain high standards of quality, and play a key role in determining the pricing and distribution of honey across the country. As the demand for natural and organic products continues to grow, the role of bulk honey suppliers will only become more critical in shaping the future of India’s honey industry. By supporting sustainable practices and ensuring the availability of high-quality honey, bulk honey suppliers will continue to contribute to the growth and evolution of the market for years to come.

[govindtbrc]

Packaging Testing Services Market: Ensuring Safety and Quality in Packaging up to 2033

Market Definition The Packaging Testing Services market includes specialized testing services for packaging materials and finished packaging products, ensuring they meet performance, durability, and regulatory standards. Packaging testing services evaluate materials’ strength, barrier properties, chemical resistance, and environmental compatibility, playing a critical role across various industries, including food and beverage, pharmaceuticals, consumer goods, and electronics. These services help businesses validate the safety, quality, and regulatory compliance of their packaging solutions before they reach the market.

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The packaging testing services market is anticipated to expand from $21.6 billion in 2023 to $38.9 billion by 2033, with a CAGR of approximately 5.8%.

Market Outlook The Packaging Testing Services market is expanding as companies across industries prioritize packaging integrity, safety, and sustainability. With increasing regulatory requirements and heightened consumer awareness about environmental impact, businesses seek reliable testing solutions to confirm their packaging is resilient, non-toxic, and eco-friendly. Packaging testing services help ensure that materials can withstand handling, shipping, and storage conditions while maintaining product safety and quality, which is particularly vital for sensitive products like food, pharmaceuticals, and electronics.

Rising demand for sustainable packaging is also driving growth in the market, with companies aiming to validate the recyclability and biodegradability of packaging materials. This trend is pushing packaging testing service providers to expand their capabilities to include environmental testing, such as lifecycle assessment, to support companies’ sustainability goals. Advancements in packaging testing technologies, including automated testing and real-time data analysis, further enhance testing accuracy and efficiency, making it easier for manufacturers to comply with industry standards and reduce costs associated with material failure.

However, the market faces challenges related to the high costs associated with comprehensive testing services, which may deter smaller businesses or those in emerging markets. Additionally, the evolving regulatory landscape and stringent standards across different regions require constant adaptation by service providers. Despite these challenges, the growing emphasis on packaging safety and sustainability, along with advancements in testing technology, are expected to sustain demand in the Packaging Testing Services market.

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[ercsprivatelimited]

What does the Bureau of Indian Standards do?

The Bureau of Indian Standards (BIS) is the National Standards Body of India, established under the Bureau of Indian Standards Act, 1986. BIS plays a vital role in the development, standardization, and quality assurance of products, services, and systems across various industries in India. Its overarching goal is to promote quality, safety, and reliability in the Indian market, ensuring that consumers and businesses benefit from standardized practices and high-quality products. Below is an in-depth exploration of the functions and responsibilities of BIS.

1. Formulating Standards

BIS is responsible for developing and maintaining national standards for products, services, and processes. These standards are created through a collaborative process involving stakeholders such as manufacturers, regulators, scientists, and consumer representatives. BIS standards cover a wide range of industries, including electronics, chemicals, textiles, food, and construction. By defining clear specifications, BIS helps maintain consistency and quality across products and services.

2. Product Certification and Licensing

One of the key functions of BIS is to provide product certification through its licensing schemes. This certification ensures that products meet the specified Indian standards and are safe for use. The well-known ISI mark, a hallmark of quality in India, is granted by BIS to certified products.

Key aspects of BIS product certification include:

Mandatory Certification: Certain products, such as electrical appliances, cement, and packaged drinking water, require mandatory BIS certification to ensure public safety.

Voluntary Certification: Manufacturers of non-mandatory products can also seek BIS certification to boost consumer trust and competitiveness.

3. Laboratory Testing and Quality Assurance

BIS operates a network of state-of-the-art laboratories where products are rigorously tested for compliance with Indian standards. These labs perform tests on a wide variety of products, ensuring that they meet quality, safety, and environmental standards. This is especially crucial for mandatory certification products that directly impact public health and safety.

4. Consumer Protection and Public Awareness

BIS plays a proactive role in protecting consumer interests by ensuring that products in the market are safe and reliable. It educates the public about the importance of purchasing certified products and how to identify genuine BIS-certified items. The organization also provides platforms for consumers to report complaints about substandard products, which are then investigated to ensure compliance.

5. Standardization in Emerging Sectors

As new industries like renewable energy, electric vehicles (EVs), and smart technologies emerge, BIS continuously expands its scope. The organization is working to develop standards for advanced products like solar panels, lithium-ion batteries, and IoT-enabled devices. By doing so, BIS ensures that India keeps pace with global technological advancements while maintaining safety and quality benchmarks.

6. Certification for Foreign Manufacturers

BIS extends its certification services to foreign manufacturers who wish to sell their products in the Indian market. The Foreign Manufacturer Certification Scheme (FMCS) allows international companies to obtain BIS certification for their products, ensuring compliance with Indian standards. This facilitates trade while protecting Indian consumers from substandard imports.

7. Training and Capacity Building

BIS conducts training programs and workshops for industry professionals, government officials, and other stakeholders. These programs aim to improve understanding of standardization, quality assurance, and certification processes. By building capacity across industries, BIS fosters a culture of compliance and quality in the Indian market.

8. Promoting Environmental Sustainability

BIS is actively involved in creating standards that promote sustainable practices. These include standards for energy efficiency, waste management, and environmentally friendly products. By encouraging businesses to adopt sustainable practices, BIS contributes to India's environmental goals and global sustainability efforts.

9. Handling Hallmarking and Certification for Precious Metals

In addition to product certification, BIS manages the hallmarking of precious metals like gold and silver. This certification ensures the purity and authenticity of these metals, protecting consumers from fraud and boosting trust in the jewelry market.

10. Market Surveillance and Compliance

BIS conducts market surveillance to ensure that certified products continue to meet the required standards. Through inspections and audits, it identifies non-compliance and takes corrective action to maintain the integrity of its certification schemes.

11. International Collaboration

BIS actively collaborates with international standards organizations such as ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission). This collaboration helps harmonize Indian standards with global practices, facilitating international trade and boosting the competitiveness of Indian products in global markets.

12. Support for Government Initiatives

BIS supports various government programs such as Make in India, Atmanirbhar Bharat (Self-Reliant India), and Digital India. By setting high standards and ensuring compliance, BIS plays a critical role in improving the quality of Indian products and promoting exports.

Conclusion

The Bureau of Indian Standards license is more than just a regulatory body; it is a cornerstone of India's quality infrastructure. By formulating standards, certifying products, and fostering consumer awareness, BIS ensures the safety, quality, and reliability of goods and services in the Indian market. Its evolving focus on emerging sectors, sustainability, and international collaboration underscores its commitment to excellence and innovation. Whether you're a consumer, manufacturer, or importer, BIS’s work directly impacts your confidence in the quality and safety of products in India.

[deshpandeisha]

Advancements in Food Allergen Testing: Ensuring Safety for Sensitive Consumers

The global food allergen testing market size reached USD 760.7 Million in 2022 and is expected to register a rapid revenue CAGR of 6.9% during the forecast period. Rising allergic reactions among consumers is a key factor driving market revenue growth. Food allergies develop when the immune system overreacts to normally harmless foods and can cause stomachache, diarrhea, dizziness, asthma, rashes, and stinging or tingling in the mouth. Food allergy testing helps to determine whether the individual is allergic to a particular food. According to research, every year around 200,000 people in the U.S. require emergency medical care for allergic reactions to food.

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Competitive Terrain:

The global Food Allergen Testing industry is highly consolidated owing to the presence of renowned companies operating across several international and local segments of the market. These players dominate the industry in terms of their strong geographical reach and a large number of production facilities. The companies are intensely competitive against one another and excel in their individual technological capabilities, as well as product development, innovation, and product pricing strategies.

The leading market contenders listed in the report are:

Intertek Group plc, SGS Société Générale de Surveillance SA, Bureau Veritas, Eurofins Scientific, Neogen Corporation, AsureQuality, Charm Sciences, Premier Analytics Servies, AES Laboratories Pvt. Ltd., and EnviroLogix

Key market aspects studied in the report:

Market Scope: The report explains the scope of various commercial possibilities in the global Food Allergen Testing market over the upcoming years. The estimated revenue build-up over the forecast years has been included in the report. The report analyzes the key market segments and sub-segments and provides deep insights into the market to assist readers with the formulation of lucrative strategies for business expansion.

Competitive Outlook: The leading companies operating in the Food Allergen Testing market have been enumerated in this report. This section of the report lays emphasis on the geographical reach and production facilities of these companies. To get ahead of their rivals, the leading players are focusing more on offering products at competitive prices, according to our analysts.

Report Objective: The primary objective of this report is to provide the manufacturers, distributors, suppliers, and buyers engaged in this sector with access to a deeper and improved understanding of the global Food Allergen Testing market.

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Market Segmentations of the Food Allergen Testing Market

This market is segmented based on Types, Applications, and Regions. The growth of each segment provides accurate forecasts related to production and sales by Types and Applications, in terms of volume and value for the period between 2022 and 2030. This analysis can help readers looking to expand their business by targeting emerging and niche markets. Market share data is given on both global and regional levels. Regions covered in the report are North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. Research analysts assess the market positions of the leading competitors and provide competitive analysis for each company. For this study, this report segments the global Food Allergen Testing market on the basis of product, application, and region:

Segments Covered in this report are:

Source Outlook (Revenue, USD Million; 2019–2032)

Peanut & Soy

Wheat

Gluten

Milk

Egg

Fish

Shellfish

Tree nut

Seafood

Others

Technology Outlook (Revenue, USD Million; 2019–2032)

Polymerase Chain Reaction (PCR)-Based

Immunoassay Based

Others

Food Tested Outlook (Revenue, USD Million; 2019–2032)

Bakery & Confectionery

Packaged Food

Dairy Products & Alternatives

Seafood & Meat Products

Beverages

Others

Browse Full Report Description + Research Methodology + Table of Content + Infographics@ https://www.emergenresearch.com/industry-report/food-allergen-testing-market

Major Geographies Analyzed in the Report:

North America (U.S., Canada)

Europe (U.K., Italy, Germany, France, Rest of EU)

Asia Pacific (India, Japan, China, South Korea, Australia, Rest of APAC)

Latin America (Chile, Brazil, Argentina, Rest of Latin America)

Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of MEA)

ToC of the report:

Chapter 1: Market overview and scope

Chapter 2: Market outlook

Chapter 3: Impact analysis of COVID-19 pandemic

Chapter 4: Competitive Landscape

Chapter 5: Drivers, Constraints, Opportunities, Limitations

Chapter 6: Key manufacturers of the industry

Chapter 7: Regional analysis

Chapter 8: Market segmentation based on type applications

Chapter 9: Current and Future Trends

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About Us:

Emergen Research is a market research and consulting company that provides syndicated research reports, customized research reports, and consulting services. Our solutions purely focus on your purpose to locate, target, and analyse consumer behavior shifts across demographics, across industries, and help clients make smarter business decisions. We offer market intelligence studies ensuring relevant and fact-based research across multiple industries, including Healthcare, Touch Points, Chemicals, Types, and Energy. We consistently update our research offerings to ensure our clients are aware of the latest trends existent in the market. Emergen Research has a strong base of experienced analysts from varied areas of expertise. Our industry experience and ability to develop a concrete solution to any research problems provides our clients with the ability to secure an edge over their respective competitors.

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