#FDAregulations

[bkmhealth]

Navigating Complex Regulatory Landscapes in Global Pharmaceuticals

In the fast-paced world of global #pharmaceuticals, BKM Health stands as a beacon of expertise, specializing in guiding pharmaceutical companies through the intricate web of regulatory requirements. From stringent #FDA approvals in the United States to compliance with Health Canada's exacting standards, BKM Health excels in ensuring that pharmaceutical products meet the highest safety and efficacy benchmarks.

Understanding Regulatory Complexity

The pharmaceutical industry operates within a complex framework of regulatory bodies and standards across different countries. BKM Health's proficiency extends across these diverse landscapes, offering tailored solutions to meet the specific regulatory challenges faced by pharmaceutical companies worldwide.

Expertise in FDA and Health Canada Compliance

In the United States, BKM Health navigates the rigorous approval processes set by the FDA with precision and expertise. They understand the nuances of FDA requirements, ensuring that products are meticulously prepared for submission and compliance. Similarly, in Canada, adherence to Health Canada's stringent pharmaceutical standards is paramount, and BKM Health provides comprehensive guidance to achieve and maintain compliance effectively.

Challenges Transformed into Opportunities

Navigating regulatory frameworks can often present challenges such as lengthy approval timelines and evolving compliance requirements. At BKM Health, these challenges are viewed as opportunities for innovation and growth. Their proactive approach ensures that pharmaceutical companies can achieve timely market entry for compliant, high-quality products, driving both innovation and profitability.

The Role of BKM Health: Strategic Guidance and Comprehensive Solutions

At the heart of BKM Health's service is a team of expert regulatory affairs professionals dedicated to delivering meticulous assessments and submissions tailored to FDA and Health Canada requirements. Their strategic insights and comprehensive solutions streamline the regulatory process, enabling pharmaceutical partners to navigate complexities effectively and efficiently.

Innovation Anchored in Strict Compliance

BKM Health is committed to championing innovation while maintaining strict regulatory compliance. By integrating advanced solutions with adherence to global standards, they empower pharmaceutical innovators to confidently bring transformative healthcare solutions to market. This approach not only enhances patient outcomes but also ensures that products meet the highest safety and efficacy standards globally.

Pioneering Future Standards in Healthcare

As the pharmaceutical landscape continues to evolve, BKM Health remains at the forefront of regulatory anticipation and adaptation. Their commitment to excellence ensures they deliver forward-thinking solutions that meet emerging global health challenges. By pioneering future standards in healthcare compliance and innovation, BKM Health continues to redefine possibilities in global healthcare.

Partnering for Success

Mastering regulatory challenges in the global pharmaceutical sector demands expertise and dedication. BKM Health's partnership approach fosters collaboration with pharmaceutical companies, helping them achieve regulatory compliance swiftly and effectively. Together, they shape the future of healthcare, driving innovation and enhancing patient outcomes worldwide.

Conclusion: Join BKM Health in Shaping Healthcare Innovation

Explore how BKM Health navigates regulatory landscapes and drives pharmaceutical innovation by visiting BKM Health's website. Discover how their commitment to compliance and innovation at its core is transforming possibilities in healthcare worldwide. read this insightful LinkedIn article. Discover how regulatory strategies are evolving and what it means for the future of healthcare.

FAQ’s

1. What specific regulatory challenges does BKM Health help pharmaceutical companies address?

BKM Health specializes in guiding pharmaceutical companies through the intricate regulatory requirements of various countries, including the rigorous FDA approvals in the United States and compliance with Health Canada's standards. We ensure that products meet the highest safety and efficacy benchmarks.

2. How does BKM Health stay updated with the evolving regulatory requirements across different countries?

Our team of regulatory affairs professionals is dedicated to staying informed about the latest changes and updates in regulatory frameworks worldwide. We continuously monitor regulatory trends and adapt our strategies to ensure compliance for our pharmaceutical partners.

3. What are the key services offered by BKM Health in relation to FDA and Health Canada compliance?

BKM Health offers comprehensive guidance tailored to FDA approvals in the United States and Health Canada's stringent pharmaceutical standards. We assist in preparing meticulous submissions and navigating the approval processes with precision.

4. How does BKM Health help pharmaceutical companies overcome lengthy approval timelines?

We view regulatory challenges as opportunities for innovation and growth. Our proactive approach and strategic insights streamline the regulatory process, helping companies achieve timely market entry for compliant, high-quality products.

5. Can BKM Health assist in global market entry beyond the US and Canada?

Absolutely. Our expertise extends to navigating regulatory landscapes in other key markets globally. We provide tailored solutions to meet specific regulatory challenges faced by pharmaceutical companies in various countries.

6. How does BKM Health balance innovation with strict regulatory compliance?

We champion innovation while ensuring strict adherence to global standards. By integrating advanced solutions with regulatory compliance, we empower pharmaceutical innovators to bring transformative healthcare solutions to market while meeting the highest safety and efficacy standards.

7. What sets BKM Health apart in the field of regulatory affairs consulting?

Our commitment to excellence and proactive approach make us a trusted partner for pharmaceutical companies worldwide. We deliver meticulous assessments, strategic guidance, and comprehensive solutions that enable effective navigation of regulatory complexities.

8. How can pharmaceutical companies benefit from partnering with BKM Health?

By partnering with BKM Health, pharmaceutical companies gain access to expertise that facilitates swift and effective regulatory compliance. Together, we shape the future of healthcare, driving innovation and enhancing patient outcomes globally.

9. How can I get started with BKM Health's regulatory consulting services?

To explore how BKM Health can help your company navigate regulatory landscapes and drive pharmaceutical innovation, visit our website or contact us directly for personalized assistance.

10. How does BKM Health contribute to shaping future standards in healthcare compliance and innovation?

We anticipate and adapt to emerging global health challenges, delivering forward-thinking solutions that set new standards in healthcare compliance and innovation. Our proactive stance ensures that we continue to redefine possibilities in global healthcare.

[enterprisewired]

FDA Proposes Ban on Brominated Vegetable Oil Due to Health Concerns

The Food and Drug Administration (FDA) has introduced a proposal to prohibit the use of brominated vegetable oil (BVO) in the United States following concerns about potential adverse health effects associated with its consumption.

The Current Regulations

This proposal, unveiled on Thursday, would effectively nullify the current regulation that permits the use of Brominated Vegetable Oil in food and beverages. BVO, a vegetable oil modified with bromine, has been authorized by the Food and Drug Administration in limited amounts to prevent the separation of citrus flavoring in certain drinks. However, recent FDA research has prompted a significant shift in the safety classification of Brominated Vegetable Oil.

The findings from these studies have uncovered that the accumulation of bromine in the body can have adverse effects on the thyroid, a vital gland responsible for producing hormones that play a crucial role in regulating blood pressure, body temperature, metabolism, and the body’s response to other hormones.

Furthermore, Brominated Vegetable Oil has been associated with various adverse effects, including irritation of the skin and mucous membranes, fatigue, loss of muscle coordination, and memory problems.

In light of these findings, the FDA now deems the continued use of BVO in food as unsafe, marking a departure from its previous designation as “Generally Recognized as Safe” (GRAS) in the 1970s.

The Food and Drug Administration issued a statement, saying, “The proposed action is an example of how the agency monitors emerging evidence and, as needed, conducts scientific research to investigate safety-related questions, and takes regulatory action when the science does not support the continued safe use of additives in foods.”

Other Manufacturers and BVO

Numerous beverage manufacturers have already reformed their product formulations by opting for alternative ingredients to replace BVO. For instance, PepsiCo removed this additive from its citrus-flavored Gatorade in 2013 due to concerns about consumers’ negative perceptions of the product.

California has also taken steps to ban Brominated Vegetable Oil and three other food ingredients within its borders, including red dye No. 3, potassium bromate, and propylparaben.

The Food and Drug Administration emphasized its commitment to continually assess the safety of various chemicals in food to align with the latest scientific knowledge and legal requirements, including recent legislation in California. The agency is also in the process of reviewing regulations related to the use of FD&C Red No. 3, and a decision regarding this chemical is expected in the near future.

To streamline the process of evaluating chemicals in the food supply moving forward, the Food and Drug Administration is in the process of establishing an “Office of Food Chemical Safety, Dietary Supplements, and Innovation.” This initiative aims to create a more efficient mechanism for assessing additives in food and ensuring their safety in the future.

Curious to learn more? Explore our articles on Enterprise Wired

[nycannabistimes]

#Repost @drbenjamincaplan ・・・ In September 2011, the FDA received a request from a doctor and a lawyer in california for an exemption under the Federal Food, Drug and Cosmetic Act (FDAC), to allow bulk cannabis and tinctures to be marketed without the requirement of an approved new drug application. Petitioners asked for an administrative hearing, but the FDA had not responded until recently with a denial of the petition and cited no proper cause for a hearing. What are your thoughts on this? . . . #cannabisnews #cannabislegalization #cannabisindustry #fdaregulations #medicalmmj #medicalcannabis #healthandwellness #naturalmedicine #cannabisfacts #dailynews #newsfacts (at Miguel Tattoos) https://www.instagram.com/p/ClUZa6EuTDx/?igshid=NGJjMDIxMWI=

[castrolhdlcom]

Healthcare and Pharmaceutical Logistics in the United States

The healthcare and pharmaceutical industries in the United States are massive, highly regulated, and intricately connected. Ensuring the efficient movement of medical supplies, pharmaceuticals, and healthcare products is essential to meet the needs of the population, especially in times of crisis, such as the COVID-19 pandemic. In this text, we will explore the logistics of healthcare and pharmaceutical products in the United States. Overview of the Healthcare System: The U.S. healthcare system is a complex web of hospitals, clinics, pharmacies, manufacturers, wholesalers, and distributors. It relies heavily on the just-in-time inventory system to minimize costs while ensuring that patients have access to the medicines and medical supplies they need promptly. #HealthcareLogistics #PharmaceuticalSupplyChain #FDARegulations

[complianceg]

FDA Issues Proposal To Amend The Medical Device Quality System Regulation

The FDA is proposing to modify the requirements of its Good Manufacturing Practices (cGMP) regulations to align them with the requirements of the ISO 13485:2016 standard for medical devices. The proposed amendments will affect the 21 CFR Part 4 regulation of combination products. They are part of the FDA’s efforts to align its regulations with the requirements of the international standard. The FDA aims to align its regulations with the requirements of other regulatory authorities in order to provide faster and more consistent access to safe and effective medical devices.

FDA’s Requirement for Manufacturers

The FDA’s requirement for manufacturers of medical devices to meet the requirements of 21 CFR Part 820 was first established in 1978. In 1997, the FDA added new design controls to the requirements for validating the safety and effectiveness of medical devices. The agency believed that this move would benefit the medical device industry and the public.

ISO 13485

The first version of ISO 13485, which was released in 1996, was focused on the requirements for the implementation of quality management systems for the medical device industry. The second edition, which was released in 2003, focused on the requirements for the regulation of these systems. The third edition, which was released in 2016, added new features and improved the quality management systems’ compliance with the requirements of 21 CFR Part 820.

The FDA is proposing to incorporate the requirements of the International Organization for Quality Management Systems (ISO 13485) in its regulations for medical devices. This would help ensure that the systems are used properly and meet the requirements of the FDA. The agency noted that the requirements of the two regulations are generally in line with each other. After the convergence of the two, the regulations for medical devices would be similar. The agency is also proposing to accept the requirements of the ISO 13485:2016 without modifying them. It will also propose a requirement that would replace the existing requirement.

The FDA is not proposing to modify the requirements of 21 CFR Part 820 for establishments that manufacture finished devices. However, the agency noted that the legal authority to require these requirements exists for certain entities. The agency noted that the proposed amendments would only address the extent of the conflicts between the conflicting regulations.

The finished device is any component or accessory that can function seamlessly on its own regardless of its packaging or labeling. A manufacturer is anyone who designs, manufactures, or processes a finished device. Nonconformity is a term that refers to the failure of a manufacturing process or component to meet a certain requirement.

Remanufacturers are those who modify or repackage a finished product to meet a specific requirement or improve its safety or performance. Rework is a process that involves taking a non-conforming product and performing a series of actions to ensure that it meets the requirements of the DMR. The validation process is a process that aims to establish that a manufacturing process consistently produces a finished product that meets its predetermined specifications.

Read more: https://www.complianceg.com/fda-proposal-to-medical-device-quality-system-regulations/

[supplementsbiz-blog]

Unless they come from the FDA or the #FTC? Don't mess with the #alphabetboys!! Always keep yourself in compliance with the Feds regs. 📚📜 Do you own or manage a 💊 #dietarysupplement #brand? Do you have questions about #FDA #RegulatoryCompliance?📝 Issues with label reviews? #Trademark or #Patent problems? We are the #dietarysupplements experts. 💪 Let us help. We are specialists in maneuvering the challenges of regulation and growth. #supplement #supplements #fdaregulatorycompliance #fdacompliance #fdaregulations #labelreviews #labels #trademarks #patents #outsourcedgeneralcounsel #dietarysupplementsexperts #supplementsexpert #supplementexpert #dietarysupplementsexpert #supplementsbusiness #supplementsbusinessadvice #supplementsbiz #supplementsbusinessexperts https://www.instagram.com/p/B2Ae1h4BRu8/?igshid=3cg14ig5j44v

[scentedexpressions-blog]

Did you know? #fdaregulations #alwaysfollowtherules #cosmeticsareregulated https://www.instagram.com/p/BpGkttuhAOY/?utm_source=ig_tumblr_share&igshid=gjf75bev8sl6

[sevillalocalmediaseo]

The latest update on FDA Cigar Regulations on the Premium Cigar Tobacco Industry. Check out the video. https://youtu.be/Yr26FEENW-k #premiumcigars #premiumtobacco #cigars #fdaregulations #cigarrights #cigarrightsofamerica https://www.instagram.com/p/BnTcAdUF2cz/?utm_source=ig_tumblr_share&igshid=cinyw1wgrgdg

[globalinstituteregulatoryaffairs]

FDA issues final rule removing certain software from medical device regulations,

More info:https://bit.ly/3obf92l

[cbdreviews]

(via Congress directs the FDA to "sample current CBD products for mislabeling & doctoring")

Congress adds 5 Marijuana, Hemp & CBD stipulations to the Federal Spending Bill. The House and Senate have agreed to include a variety of marijuana, hemp and CBD stipulations in reports attached to appropriations legislation that President Trump signed into law this past Friday. Congress also directed the FDA to “perform a sampling study of the current CBD marketplace to determine the extent to which products are mislabeled or adulterated” and report back to legislators within 180 days. More information: https://www.cbd.how/congress-directs-the-fda-to-sample-current-cbd-products-for-mislabeling-doctoring #fda #fdaregulations #cbdregulations #hemp #cbd #cbdhow #cbdoil #cbd  

[complianceg]

What is the FDA’s approach to regulating AI/ML in SaMD (software as a medical device)?

As the quote goes, “Necessity is the mother of invention.” Ironically, we don’t know who invented that quote. It became an amalgam of people from Plato to a 19th-century theologian.

According to the FDA’s site, their first Medical Device approved was in 1976 through their CDHR division (Center for Devices and Radiological Health) per their 21CFR Parts 800-1299. As we know, medical devices fall into three categories, from low risk to high risk: Class I, II, and III

Per the Int’l Med Device Regulators Forum (IMDRF), the need for regulating SaMD, this new form of med device, came about as long ago as 2013, again through an amalgam of regulated elements within the med device world.

“SaMD” even reaches as far back as the 60s with Lockheed’s consideration of getting the first computerized information-handling system in the hospital sphere.

And do we know who the first company was to be approved by the FDA as a SaMD? I’m sure there was a hybrid that led up to that, and my guess is it’s archived somewhere, but my research didn’t come up with a specific name, but rather several SaMD firsts:

• Pacemakers • X-rays and MRIs • Bedside monitors • Urine analyzers • Glucometers • Spirometers

The FDA had a tall order to decipher regulatory compliance with this new hybrid. And companies in the SaMD space had to figure out how to manage regulatory affairs per the FDA.

Thanks to SaMD and other inventions, Artificial Intelligence (AI) and Machine Learning (ML) are pervasive in nearly everything we do now. Are Alexa, OK Google, and Siri listening and learning? Absolutely. Is their AI helping us with more targeted options for buying, listening, and purchasing… even routing us to avoid traffic? Definitely. Conversely, have you ever looked up airfare, car rentals, and hotels, only to find out after your third or fourth search that the prices went up for some reason…on the same day? Hmmm. What changed that? Supply and demand…AI/ML interpreted your multiple searches (and others) as increased demand, so they bump up the price a bit more or a lot more. This “encourages” you to buy quicker. Maybe using Incognito or an anonymous site helps? What are your thoughts?

Would SaMD do the same? Not unless the developing company wanted to violate HIPAA compliance and all kinds of regulatory violations.

For some guidance, per Deloitte, here are some Is and Is Not examples:

 What is and is not SaMD?

 SaMD

Software that can determine the  proper drug dose for a patient, given personalized patient data

Software that can detect and  diagnose a stroke by analyzing MRI images

Software that can track the size of  a mole over time and determine the risk of melanoma

Software that draws on data from  other digital devices to determine risk factors associated with epileptic  seizures

Not SaMD

Software that operates a pacemaker

Software that drives or controls an  infusion pump’s motors

Electronic health record systems

Software in the machines that  assemble medical devices

In one of my previous blogs, I mentioned that Apple, which started in 1976, hit it big with its desktops, but even bigger more significant with their iPhone innovation. That iPhone, coupled with the right software, became one of the forefront integrators of SaMD. Suddenly, eyes were opened to a world of information, whether on our wrist or transported electronically to the doctor. Abruptly, our eyes opened to a universe of data, accessible on our wrist and to be shipped electronically to our primary care physician.

Thanks to necessity, we can live healthier and longer and invent more!

[supplementsbiz-blog]

Did you know that 75% of U.S. adults take dietary supplements? Do you own or manage a #dietarysupplement #brand? Do you have questions about #FDA #RegulatoryCompliance? Issues with label reviews? #Trademark or #Patent problems? We are the #dietarysupplements experts. Let us help. We are specialists in maneuvering the challenges of regulation and growth. #supplement #supplements #fdaregulatorycompliance #fdacompliance #fdaregulations #labelreviews #labels #trademarks #patents #outsourcedgeneralcounsel #dietarysupplementsexperts #supplementsexpert #supplementexpert #dietarysupplementsexpert #supplementsbusiness #supplementsbusinessadvice #supplementsbiz #supplementsbusinessexperts https://www.instagram.com/p/B1UlXQzBwEO/?igshid=5ilh9dmfyp57

[pipevape-blog]

Jep. Und plötzlich wird aus PG / VG, Lebensmittel Aromen, und womöglich Nikotin, zu 'Tabak' erklärt, und sogar als GIFTIGER als Verbrannte, über 1000 verschiedene, NICHT DEFINIERBARE, KREBSERREGENDE Komponente. Schön, wenn Tabakriesen das NICHT KREBSERREGENDE Dampfen ERWÜRGT!

[lorithegovlibrarian]

If you're a big fan of antibacterial soaps and body washes, you may want to run out and stock up.  The Food and Drug Administration has issued a new rule that manufacturers will no longer be able to sell products with certain antibacterials ingredients.  This announcement from the FDA explains why. Germaphobes can still rest easy--hand sanitizers are not affected by this rule.

[infamousfk]

I shared a post by my middle kid sharing a petition on wethepeople.gov about the upcoming (T-26 days) ban on Kratom. They posted this because they have seen the dramatic difference this herb has made in my life, having seen it first hand. In addition to patents held by Smith-Kline Pharmaceuticals on one of the alkaloids in Kratom, and a Japanese pharmaceutical company holding patents on the pain-relieving alkaloids from it, there are posts across the internet talking about how this leaf from a relative of coffee has changed lives - for chronic pain sufferers, people who struggle with depression (I fall in to both categories), and others, this herb has been a bridge to get off multiple medications and be a more functional human being. 

I beg you - spend a few minutes reading about kratom and the people it has helped. Then go sign the petition at https://wh.gov/iLACs , asking President Obama to urge a more balanced look at this. Colleges and researchers are working to find the best way to use kratom to fight the opioid epidemic. This move by the FDA will stop that research cold. It shouldn’t be this way, but also shouldn’t be a surprise with an FDA head who testified to Congress that he works for the pharmaceutical companies.

[mamas-still-doing-it-all]

Since when did my pain become a federal issue?

mamas-still-doing-it-all