#thefda

[labcoatandsafetygogglesaesthetic]

Is there a way to @theFDA like I volunteer to get all the covid vaccines

[robiuldesigner]

Click here : www.fiverr.com/share/jdjWE9 - - - - - - #Virgo #Fiddler #Basquiat #Kobe #Pfizer #RespectBiden #FightClub #TheFDA #VisibleWomen #Carti #Cross #WHULEI #JoeyChestnut #Entry #Kacey #Boosie #Kanye

[worldnewsinpictures]

The acting head of the FDA is calling for a government investigation into highly unusual contacts between her agencys drug reviewers and the maker of a controversial new Alzheimers drug. Is thats why it got approved? Holy cow is everyone on the take?... Do you have an opinion on this? Share it! HERE -> https://worldnewsinpictures.com/acting-head-fda-calling-government #TheFDA #TheFDAAlzheimers #Share #ShareHERE #acting #calling #government

[beverleyperkins]

And support the efforts of our teachers

{MK Outlet Store, } In some areas, employers will prohibit the use of mobile phones to prevent the possibility of a spark being generated that might ignite flammable materials. This may also be to protect against the risk that some critical electronic control systems may experience interference and fail. The Health and Safety Executive advises employers that they should instruct staff not to use mobile phones while driving, or while doing anything else where concentration is important and their use might interfere with safety. {Coach Outlet Clearance, } What causes decay? When foods with carbohydrates like bread, cereal, milk, soda, fruit, cake, or candy stay on your teeth. The bacteria in your mouth turn them into acids. The bacteria, acid, food debris, and your saliva combine to form plaque, which clings to the teeth. The house sits in the middle of a riverfront industrial district. The landscape is railroad tracks and tanker cars, abandoned metal buildings. The air conditioning is out, so the conversation is on the semi shaded front porch, with their pit bull, Coco, and her puppies. {Coach Bags Clearance, } Held in check by a new 10 speed automatic transmission. We haven't driven it yet, we're holding our breath till then. The previous generation ZL1 was an amazing performer while being very livable for everyday driving. The mercury contained in the amalgam releases low levels of mercury in the form of a vapor that can be inhaled and absorbed by the lungs. High levels of mercury vapor exposure are associated with adverse effects in the brain and the kidneys. Studies have found no link between the amalgam filinings and health problems and theFDA considers them safe for adults and children ages 6 and above.

[dreddymd]

Hygiene 101: Hand sanitizers work, but handwashing gets rid of more germs, explain scientists

While hand sanitizers work, handwashing is still the gold standard for hygiene as it kills more germs. According to Penn State Health Milton S. Hershey Medical Center physician Dr. Roland Newman II, while there’s truth in the claims saying that hand sanitizers can kill 99 percent of germs, some pathogens can still sneak through.

Handwashing is still the best

According to Newman, not all hand sanitizers are effective at killing certain pathogens, such as the norovirus. The norovirus is a highly infectious virus that causes vomiting and diarrhea. Studies also show that hand sanitizers are not as good as handwashing at getting rid of the parasite Cryptosporidium and the bacterium Clostridium difficile, both of which can cause diarrhea.

Other studies have found that hand sanitizers with less than 60 percent alcohol are less effective at killing bacteria and fungi. In addition, they could only reduce the spread of germs, not eliminate them outright.

Handwashing is still the way to go, especially when the hands are visibly soiled. However, Newman pointed out that there are still handwashing protocols that need to be followed. He also said that you need to rub your hands vigorously with soap for at least 20 seconds, or about as long it takes to sing “Happy Birthday” or finish the alphabet, to clean your hands thoroughly.

“What the soap does as you are scrubbing is release all the dirt and germ particles from the surface of the skin,” explained Newman. The pathogens get bound up in the soap lather and are washed off upon rinsing. It doesn’t matter if the water is cold or warm. What’s important is how long you’ve spent properly scrubbing and rinsing your hands.

But if soap and water are not readily available, Newman recommends using hand sanitizers with at least 60 percent alcohol. “For the average person, they are super convenient, and I think they do have a place in hand hygiene,” he said. Hand sanitizers could also be effective against the SARS-CoV-2, the virus responsible for the Wuhan coronavirus (COVID-19) pandemic.

Choosing soaps and hand sanitizers wisely

Not all hygiene products are created equal, so it’s important to choose soaps and hand sanitizers wisely. The Food and Drug Administration (FDA) recommends using regular soap and alcohol-based hand sanitizers. These could effectively do the job of killing microbes even without the additives commonly found in antibacterial washes.

In fact, chemical additives may do more harm than good. Research suggests that bacteria exposed to triclosan, an antimicrobial chemical found in antibacterial soap, mouthwash, makeup and toothpaste, promotes the development of antibiotic resistance. In 2016, theFDA banned the use of triclosan and 18 other chemicals in household soap products.

“Consumers may think antibacterial washes are more effective at preventing the spread of germs,” said Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, “but we have no scientific evidence that they are any better than plain soap and water.”

Meanwhile, the FDA advises consumers to be careful when selecting their hand sanitizers. The agency recently added 202 hand sanitizers to its “do not use” list, including those that tested positive for methanol contamination. Methanol can be deadly when ingested, besides being potentially toxic when absorbed through the skin. (Related: How to make DIY antibacterial hand sanitizer using non-toxic ingredients.)

Visit Prevention.news for more tips on how to prevent diseases caused by microbial infections.

Virgilio Marin

Sources include:

NewsWise.com

TheConversation.com

PopSci.com

Health.Harvard.edu

FDA.gov 1

FDA.gov 2

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Naturally Disinfect Your Kitchen of Germs and Bacteria

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[bxnnxrxd]

“ As I understand it during the Depression food like that was being given like the equivalent of homeless shelters today. And the reason we don’t really have street food like this in the US is because of theFDA. There are so many rules and guidelines and they don’t want food poisoning and lawsuits. Other countries? All the street food you could dream of and all sorts of flavors. “ He popped another little ball of bread into his mouth, thinking. “ Let’s see, we can try some esfiha.. and oh!! Tapioca! And it’s not pudding but it is a dessert. “ He smiled rather brightly that time. There were plenty of people out, music and lights bright if the way as they wandered. “ Your call. “

Hunting Season

What had he done? Of trying to hide from the government, Ross, and the rest wasn’t enough now he had Captain America hunting him down like a dog. He was just trying to figure out a way to control his transformations. It had been a while since he’d turned into the Hulk, but then the assault team cornered him. And then.. Hulk must have killed six people back there, but it was self defense. When cornered all that fear and rage just came bursting out. He’d been lucky enough that Hulk escaped the famous war hero, and that team.

Bruce had gone to one of his tiny safe houses in Brazil. And it was there, that the wretch of a broken man was staring at a gun with a contemplative look. Maybe if he just tried to end it again. One shot, instead of a cure for what was happening. He was still reeling from what happened in his broken down little hobble that barely had anything in it except jimmy rigged equipment for experimentation. He was quiet, but shirtless, just sitting on the floor in a different set of pants as his had been massacred.

Glancing to the firearm, Bruce shifted his gaze toward a bottle of cheap whiskey, taking a drink from it. “ .. You fucked things for good, Banner. You killed more people. .. six, seven men? God knows if any civilians were hurt..”

[plantman-dan]

So now that I have access to fresh beeswax, I've been playing around with the rendering methods and some salve recipes, hopefully up next is candles. I think the ratios are coming together. I'm testing two salves, one as a natural healing ointment - for minor cuts, scrapes, burns, bug bites - and two as an all-day all-purpose - for anywhere, from head to toe skin goodness. _☀️ The one posted here is the all-day, which has a blend of shea butter, olive oil, coconut oil, and peppermint and rosemary essential oils. This salve will help soothe tired, dry skin, even hair and makes great lip balm. _⚕ The healing salve has a blend of; propolis (tree sap and oils that bees collect to seal cracks in the hive and sanitize cells before a new egg is laid), honey, tea tree, lavender, and eucalyptus essential oils. This blend is a powerhouse of naturally occurring anti-microbial, anti-bacterial, antiseptic, and anti-viral properties* _��� Would anyone be interested in these? _🐝 #beeswax #salves #healingsalve #healinghoneysalve #localpopolis #honeybeepropolis #propolis #localhoney #honey #localbeeswax #smallbatch #handmade #beekeeping #beekeepers #apiculture #apiary #apis #honeybees #bees #wax #thefda #optoutside #findyourway #beekeepingtherapy #hivemind #supportlocal _🏛 *These statements have not been evaluated by the Food and Drug Administration (FDA). This product is not intended to diagnose, treat, cure, or prevent any disease. https://www.instagram.com/p/B5jW5WpgR_d/?igshid=1o8igyrpq90md

[newsmatters]

FDA rejects EUA for Covaxin, 'suggests' Biologics Licence Application route for approval in US

FDA rejects EUA for Covaxin, ‘suggests’ Biologics Licence Application route for approval in US

In a setback to Bharat Biotech’s COVID-19 vaccine Covaxin, the US Food and Drug Administration has “recommended” Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixing hopes of Emergency Use Authorisation. Ocugen in a statement on Thursday announced that as recommended by theFDA, it will pursue sub mission of a…

[larebomrglobal]

US Dental care Equipment Market Growth, Size, Share and Industry Report to 2019-2025

The US dental care equipment market is anticipated to grow at a CAGR 5.3% during the forecast period. The US is the major country in the North American region and has a major market share during the forecast periods. Hospital care expenditures showed mixed trends across the major payers, with slower growth in Medicaid and private health insurance spending, stable growth in Medicare spending, and faster growth in out-of-pocket spending. Increasing applications and research on lasers in dentistry continues to expand since they are introduced to the dental profession. Dental laser systems are cleared for marketing in the US via theFDA Premarket Notification [510(k)] process. The US is the only region to have commercialization of dental laser system.

Request a Free Sample of our Report on US Dental care Equipment Market https://www.omrglobal.com/request-sample/us-dental-care-equipment-market

Moreover, rising geriatric population is also one of the major factors that drive the US region during the forecast period. The rising aging populations are more prone to dental diseases such as gum, mouth, tooth related and so on. Hence, requiring dental care equipment to treat the diseased mouth.

A full Report of US Dental care Equipment Market is Available at: https://www.omrglobal.com/industry-reports/us-dental-care-equipment-market

The report is intended for the, dental care equipment manufacturers and other related companies for overall market analysis and competitive analysis. The report provides an in-depth analysis of market size, intended quality of the service preferred by consumers. The report will serve as a source for a 360-degree analysis of the market thoroughly integrating different models.

US Dental care Equipment Market Segmentation

By Radiology Equipment

Intraoral Radiology Equipment

Extraoral Radiology Equipment

By Dental Lasers

Diode Lasers

Carbon Dioxide Lasers

Yttrium Aluminium Garnet Lasers

By Laboratory Machines

Ceramic Furnace

Hydraulic Press

Electronic Waxer

Suction Unit

Micro Motors

By Hygiene Maintenance Devices

Sterilizers

Air Purification & Filters

Hypodermic Needle Incinerator

By Systems and Parts

Instrument Delivery Systems

Vacuums & Compressors

Cone Beam And Ct Systems

Cast Machine

Furnace And Ovens

Electrosurgical Equipment

CAD/CAM

By Other Equipment

Dental Chairs

Handpieces

Scaling Unit

Light Cure

Company Profiles

3M Co.

A-DEC, Inc

AMD Lasers, LLC

Biolase, Inc

Carestream Dental, LLC

Danaher Corp.

Dentsply Sirona International, Inc

Henry Schein, Inc.

Hu-Friedy MGF Co.

Midmark Corp.

Patterson Companies Inc.

Ultradent Products, Inc.

Zimmer Biomet

A full Report of US Dental care Equipment Market is Available at: https://www.omrglobal.com/report-customization/us-dental-care-equipment-market

About Orion Market Research

Orion Market Research (OMR) is a market research and consulting company known for its crisp and concise reports. The company is equipped with an experienced team of analysts and consultants. OMR offers quality syndicated research reports, customized research reports, consulting and other research-based services.

For More Information, Visit Orion Market Research

Media Contact:

Company Name: Orion Market Research

Contact Person: Mr. Anurag Tiwari

Email: info@omrglobal.com

Contact no: +1 646-755-7667, +91 780-304-0404

[drawingisgood-blog]

Green Roads Cbd Oil Stock Where Does One Buy

New Post has been published on https://www.cannabisoilforsale.org/green-roads-cbd-oil-stock-where-does-one-buy/

Green Roads Cbd Oil Stock Where Does One Buy

last week the FDA had hearings on CBDwith CVD stakeholders and Leafly commcame out with five takeaways from theFDA and the FDA is concern about CVDbeing...

[repwincostl4m0a2]

Trump Nominates FDA Head With Deep Ties To Drug Companies

WASHINGTON, March 10 (Reuters) - U.S. President Donald Trump has chosen Dr. Scott Gottlieb, a conservative health policy expert with deep ties to the pharmaceutical industry, to lead the U.S. Food and Drug Administration, a White House official said on Friday.

If confirmed by the Senate, Gottlieb would be in charge of implementing Trump’s plan to dramatically cut regulations governing food, drugs, cosmetics, dietary supplements and tobacco.

Gottlieb is well known on Capitol Hill, where he has testified multiple times on hot-button health issues, including complex drug pricing matters, and is viewed favorably by drug companies and pharmaceutical investors. A former FDA official, Gottlieb also sits on the board of pharmaceutical companies.

“Thank God it’s Gottlieb,” Brian Skorney, an investment analyst at Robert W. Baird, wrote in a research note. “We view this as a favorable development for the sector.”

Gottlieb, 44, is a resident fellow at the conservative American Enterprise Institute think tank and a partner at a large venture capital fund. He is a former FDA deputy commissioner who has frequently advocated a loosening of requirements needed for approval of new medical products.

“Scott knows how the agency works and he will move it forwards, though maybe not always in ways the agency is comfortable with,” said John Taylor, a lawyer and president of compliance and regulatory affairs with the consulting firm Greenleaf Health and a former acting FDA deputy commissioner.

Gottlieb was chosen over Jim O’Neill, a libertarian investor close to Silicon Valley billionaire Peter Thiel, a PayPal co-founder who now advises Trump on technology and science matters. O’Neill’s stated view that drugs should be approved before being proven effective generated widespread alarm.

Gottlieb, who declined to comment on the nomination, is unlikely to up-end the FDA in the way O’Neill might have, but he is nonetheless expected to bring significant change, including moving the agency to increase flexibility in the clinical trial development process.

In this he will be supported by the recently passed 21st Century Cures Act which instructs theFDA among other things to consider the use of “real world evidence” to support new drug applications. This could include anecdotal data, observational studies and patient reports

“People don’t want to take chances with safety, but there’s increasingly some clamor to be more flexible on the efficacy side,” said Kathleen Sanzo, who leads the FDA practice at the law firm Morgan, Lewis & Bockius. “You need to have some signal of efficacy. The question is, how much?”

One of Gottlieb’s priorities will likely be to streamline the process for approving generic versions of complex, difficult-to-copy therapeutics. He has stated publicly that he does not believe the FDA has good tools or policies to move such products and has advocated the creation of different approval standards.

A survey conducted by Mizuho Securities USA Inc of 53 pharmaceutical executives found that 72 percent favored Gottlieb over other potential candidates. Many described him as knowledgeable, experienced and balanced.

“He will be a pragmatic leader with an eye toward both expedited approvals and safety,” one executive wrote.

Others were less sanguine, citing his deep ties to industry, including his seat on multiple pharmaceutical company boards, as potential conflicts of interest.

Dr. Michael Carome, director of Public Citizen’s Health Research Group, said Gottlieb “has spent most of his career dedicated to promoting the financial interests of the pharmaceutical industry.” If confirmed, he added, “he will have to be recused from key decisions time and time again.”

CLINICAL TRIAL FLEXIBILITY

The FDA has attempted to push back against moves to sideline randomized clinical trials, long considered the gold standard. In January it issued a report documenting 22 cases in which drugs that appeared to show promise in early trials turned out to be either ineffective or unsafe or both in larger trials.

But it has already moved to decrease the requirements for proving that a drug works.

Last year, Dr. Janet Woodcock, the agency’s powerful head of pharmaceuticals, ordered the approval of Sarepta Therapeutics Inc’s drug to treat Duchenne muscular dystrophy based on little more than a hint of efficacy.

In doing so she overrode the recommendation of a panel of outside advisors and top scientists at the agency and set what some say is a precedent for approving drugs based on minimal data.

“How can you say it’s OK for this company but not that company?” Mark Mansour, a partner with the law firm Mayer Brown LLP said. “The administration is going to be pushing for quicker approval of drugs for all sorts of diseases with similar, vociferous patient populations who are crying out for a solution.”

Other companies that may benefit from Gottlieb’s presence are manufacturers of electronic nicotine delivery systems such as e-cigarettes. The American Enterprise Institute has consistently argued that there is no evidence to show that the risk of vaping comes near to the risk of smoking. Between 2005 and 2007 he was FDA deputy commissioner for medical and scientific affairs. Previously he was a senior advisor to the commissioner and acted as the agency’s director of medical policy development.

(Reporting by Toni Clarke; Editing by Alistair Bell and Lisa Shumaker)

-- This feed and its contents are the property of The Huffington Post, and use is subject to our terms. It may be used for personal consumption, but may not be distributed on a website.

from DIYS http://ift.tt/2n8W6su

[worldnewsinpictures]

Americas #FDA chief defends prolonged approval process for #COVID19 vaccine after Trump calls agency big, old, slow turtle. The FDA is one of the largest criminal enterprises in the world.... Do you have an opinion on this? Share it! HERE -> https://worldnewsinpictures.com/americas-fda-chief-defends-prolonged-approval #Americas #AmericasFDA #AmericasFDACOVID19 #TheFDA #TheFDAShare #defends #prolonged #approval

[worldnewsinpictures]

The FDA has just authorized the Pfizer ######COVID19 vaccine for emergency use. CA expects to receive our initial allotment of 327,600 doses as early as this weekend. California is a dumpster fire. I wish you would just go away.... Got an opinion about this? See what others are saying.... See MORE -> https://worldnewsinpictures.com/covid19 #TheFDA #TheFDAPfizer #California #CaliforniaGot #CaliforniaGotSee #authorized #Pfizer #COVID19 #vaccine

[newsmatters]

US FDA rejects emergency authorisation for Covaxin, 'recommends' to take full approval route- The New Indian Express

US FDA rejects emergency authorisation for Covaxin, ‘recommends’ to take full approval route- The New Indian Express

By PTI HYDERABD: In a setback to Bharat Biotech’s COVID-19 vaccine Covaxin, the US Food and Drug Administration has “recommended” Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixinghopes of Emergency Use Authorisation. Ocugen in a statement on Thursday announced that as recommended by theFDA,it will pursue…

[larebomrglobal]

The US is the major country in the North American region and has a major market share during the forecast periods. Hospital care expenditures showed mixed trends across the major payers, with slower growth in Medicaid and private health insurance spending, stable growth in Medicare spending, and faster growth in out-of-pocket spending. Increasing applications and research on lasers in dentistry continues to expand since they are introduced to the dental profession. Dental laser systems are cleared for marketing in the US via theFDA Premarket Notification [510(k)] process. The US is the only region to have commercialization of dental laser system.

[repwincostl4m0a2]

Trump Nominates FDA Head With Deep Ties To Drug Companies

WASHINGTON, March 10 (Reuters) - U.S. President Donald Trump has chosen Dr. Scott Gottlieb, a conservative health policy expert with deep ties to the pharmaceutical industry, to lead the U.S. Food and Drug Administration, a White House official said on Friday.

If confirmed by the Senate, Gottlieb would be in charge of implementing Trump’s plan to dramatically cut regulations governing food, drugs, cosmetics, dietary supplements and tobacco.

Gottlieb is well known on Capitol Hill, where he has testified multiple times on hot-button health issues, including complex drug pricing matters, and is viewed favorably by drug companies and pharmaceutical investors. A former FDA official, Gottlieb also sits on the board of pharmaceutical companies.

“Thank God it’s Gottlieb,” Brian Skorney, an investment analyst at Robert W. Baird, wrote in a research note. “We view this as a favorable development for the sector.”

Gottlieb, 44, is a resident fellow at the conservative American Enterprise Institute think tank and a partner at a large venture capital fund. He is a former FDA deputy commissioner who has frequently advocated a loosening of requirements needed for approval of new medical products.

“Scott knows how the agency works and he will move it forwards, though maybe not always in ways the agency is comfortable with,” said John Taylor, a lawyer and president of compliance and regulatory affairs with the consulting firm Greenleaf Health and a former acting FDA deputy commissioner.

Gottlieb was chosen over Jim O’Neill, a libertarian investor close to Silicon Valley billionaire Peter Thiel, a PayPal co-founder who now advises Trump on technology and science matters. O’Neill’s stated view that drugs should be approved before being proven effective generated widespread alarm.

Gottlieb, who declined to comment on the nomination, is unlikely to up-end the FDA in the way O’Neill might have, but he is nonetheless expected to bring significant change, including moving the agency to increase flexibility in the clinical trial development process.

In this he will be supported by the recently passed 21st Century Cures Act which instructs theFDA among other things to consider the use of “real world evidence” to support new drug applications. This could include anecdotal data, observational studies and patient reports

“People don’t want to take chances with safety, but there’s increasingly some clamor to be more flexible on the efficacy side,” said Kathleen Sanzo, who leads the FDA practice at the law firm Morgan, Lewis & Bockius. “You need to have some signal of efficacy. The question is, how much?”

One of Gottlieb’s priorities will likely be to streamline the process for approving generic versions of complex, difficult-to-copy therapeutics. He has stated publicly that he does not believe the FDA has good tools or policies to move such products and has advocated the creation of different approval standards.

A survey conducted by Mizuho Securities USA Inc of 53 pharmaceutical executives found that 72 percent favored Gottlieb over other potential candidates. Many described him as knowledgeable, experienced and balanced.

“He will be a pragmatic leader with an eye toward both expedited approvals and safety,” one executive wrote.

Others were less sanguine, citing his deep ties to industry, including his seat on multiple pharmaceutical company boards, as potential conflicts of interest.

Dr. Michael Carome, director of Public Citizen’s Health Research Group, said Gottlieb “has spent most of his career dedicated to promoting the financial interests of the pharmaceutical industry.” If confirmed, he added, “he will have to be recused from key decisions time and time again.”

CLINICAL TRIAL FLEXIBILITY

The FDA has attempted to push back against moves to sideline randomized clinical trials, long considered the gold standard. In January it issued a report documenting 22 cases in which drugs that appeared to show promise in early trials turned out to be either ineffective or unsafe or both in larger trials.

But it has already moved to decrease the requirements for proving that a drug works.

Last year, Dr. Janet Woodcock, the agency’s powerful head of pharmaceuticals, ordered the approval of Sarepta Therapeutics Inc’s drug to treat Duchenne muscular dystrophy based on little more than a hint of efficacy.

In doing so she overrode the recommendation of a panel of outside advisors and top scientists at the agency and set what some say is a precedent for approving drugs based on minimal data.

“How can you say it’s OK for this company but not that company?” Mark Mansour, a partner with the law firm Mayer Brown LLP said. “The administration is going to be pushing for quicker approval of drugs for all sorts of diseases with similar, vociferous patient populations who are crying out for a solution.”

Other companies that may benefit from Gottlieb’s presence are manufacturers of electronic nicotine delivery systems such as e-cigarettes. The American Enterprise Institute has consistently argued that there is no evidence to show that the risk of vaping comes near to the risk of smoking. Between 2005 and 2007 he was FDA deputy commissioner for medical and scientific affairs. Previously he was a senior advisor to the commissioner and acted as the agency’s director of medical policy development.

(Reporting by Toni Clarke; Editing by Alistair Bell and Lisa Shumaker)

-- This feed and its contents are the property of The Huffington Post, and use is subject to our terms. It may be used for personal consumption, but may not be distributed on a website.

from DIYS http://ift.tt/2n8W6su