FDA issues warning to 5 companies selling dietary supplements containing cesium chloride

The Food and Drug Administration (FDA) issued a warning to five companies currently marketing dietary supplements containing cesium chloride in letters posted on Tuesday. The FDA has previously warned consumers and health care professionals against using supplements containing cesium salts after the health agency found significant safety risks associated with it being used in compounded drugs.

“The FDA will continue to take action against dietary supplements that contain cesium chloride because of significant safety concerns – including heart toxicity and potential death – associated with this ingredient,” Steven Tave, director of the office of dietary supplement programs in the FDA’s Center for Food Safety and Applied Nutrition, said. “We take very seriously our role to protect the public from dangerous dietary supplements.”

FDA FAULTS QUALITY CONTROL AT LILLY PLANT MAKING TRUMP-TOUTED COVID-19 DRUG

The regulatory agency requires companies

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FDA pushes back on Trump administration attempt to rebrand ‘emergency authorization’

While Congress mandated earlier this year that Medicare cover the cost of administering a licensed vaccine, the requirement did not include drugs authorized under emergency-use designations. That’s raised the prospect that millions of people could be forced to pay out of pocket unless Congress were to adopt a quick fix.

HHS officials over the past month thought they found a solution, with Charrow arguing that the FDA should make clear that emergency authorization of a Covid-19 vaccine is equal to a “pre-licensure,” and should be covered by Medicare as a result, the officials said.

But Hahn firmly opposed the idea, amid concerns that failing to stick to the FDA’s technical language would erode the agency’s credibility and open it up to accusations that it’s allowing politics to influence its role in the Trump administration’s vaccine hunt.

“Hahn is hell bent against any modification of definitions, because it would be viewed

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Viewpoints: FDA Guidance On Vaccine Brings Relief At Right Time; Lessons On Talking Public Health To Conservatives

Opinion writers weigh in on these pandemic topics and others as well.


Bloomberg:
FDA Is Right To Hold Covid-19 Vaccines To High Safety Standards 


The FDA’s rules will indeed make it hard for a vaccine to be approved before Nov. 3 — but they’re no political ploy. They’re essential to assure the country that any shot the FDA approves quickly will be safe and effective. It’s disgraceful that, to do its job, the agency was forced to make an end run around the president. That’s hardly the FDA’s fault. Faced with a boss who often belittles them and refuses their advice without understanding it, what are the experts to do? (10/12)

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Simulations Plus Teams Up with the University of Health Sciences and Pharmacy in St. Louis to Secure New Grant Award from the U.S. FDA


Simulations Plus, Inc. (Nasdaq: SLP), the leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, today announced that, through a joint proposal with the St. Louis College of Pharmacy at University of Health Sciences and Pharmacy in St. Louis, it has been awarded a new funded cooperative agreement from the U.S. Food and Drug Administration (FDA) to establish novel in vitro/in silico models for the oral cavity route of administration in GastroPlus® to accelerate pharmaceutical research and regulatory assessment of innovative and generic drug products delivered intraorally.


For this award, researchers at the University of Health Sciences and Pharmacy in St. Louis will generate data for marketed buccal and sublingual products using both standard in vitro systems and the innovative Dynamic In Vitro Dissolution and Absorption Model (DIVDAM) designed in their labs. The team at Simulations Plus will apply these

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Trump sparks new FDA concerns with praise of ‘miracle’ treatment

President Trump’s public praise for an experimental coronavirus antibody treatment is putting new pressure on the Food and Drug Administration (FDA) to quickly give emergency clearance to a drug he has touted as a “miracle.”



a person sitting on a table: Trump sparks new FDA concerns with praise of 'miracle' treatment


© Getty Images
Trump sparks new FDA concerns with praise of ‘miracle’ treatment

Doctors think the drugs show promise as a potential treatment of COVID-19, though Trump has created confusion by quickly elevating them to a cure.

“They call them therapeutic, but to me it wasn’t therapeutic,” Trump said in a video he tweeted on Wednesday, five days after receiving the experimental treatment from the biotech company Regeneron.

Trump said that he felt better immediately after taking the drugs.

“I call that a cure,” he said. “It’s a cure.”

But by placing himself in the middle of the drug evaluation process, Trump is once again igniting concerns that politics is encroaching on science at

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FDA Updates Health and Personal Hygiene Handbook for Food Employees

Constituent Update

October 7, 2020

The U.S. Food and Drug Administration (FDA) has released an updated version of the Employee Health and Personal Hygiene Handbook for retail food managers and food employees. The handbook includes best practices and behaviors that can help prevent food employees from spreading bacteria and viruses, such as Salmonella and norovirus, that cause foodborne illness. This handbook has been revised  to include updates from the 2017 Food Code. While the Food Code does not address respiratory illness, such as COVID19, the Employee Health section emphasizes   long-standing public health principles for preventing disease transmission – hand washing; excluding ill employees from the workplace, prohibiting bare-hand contact with ready-to-eat foods; and reporting of illness and symptoms, among others.

Updates to the handbook include:

  • The addition of nontyphoidal Salmonella (NTS) as one of the reportable illnesses for action by the Person in Charge (PIC) in a retail food establishment;
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FDA Reaffirms Commitment to Safety, Security of its Public Health Laboratories

For Immediate Release:
October 08, 2020
Statement From:

Statement Author

Leadership Role

Commissioner of Food and Drugs – Food and Drug Administration

Stephen M. Hahn
M.D.

The U.S. Food and Drug Administration’s mission to protect and promote public health by ensuring the safety of the nation’s food supply, as well as the safety and efficacy of medical products, has always relied on a rigorous analysis of the scientific data available and a strong commitment to safety. We are dedicated to helping ensure the safety of the American public through our work and the safety of all of our staff by continuing to support and strengthen a culture that prioritizes workplace safety.

FDA staff across the nation work diligently to help ensure the safety of FDA-regulated products. I’ve seen this same dedication in their shared commitment to protecting each other and prioritizing safety across the agency, including our laboratories across the

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Regeneron requests EUA from the FDA for coronavirus treatment

Regeneron’s stock price rose over 4% in premarket trading Thursday after the company submitted an “emergency use authorization” request to the U.S. Food and Drug Administration for its Covid-19 antibody treatment.

Its REGN-COV2 monoclonal antibody coronavirus therapy is what President Donald Trump took last week after being diagnosed with Covid-19. He has since described it as a “cure” even though there’s no such scientific proof. 

The biotech company published a statement Wednesday noting that “if an EUA is granted the  government has committed to making these doses available to the American people at no cost and would be responsible for their distribution.”

The treatment is now available for about 50,000 patients, Regeneron said, “and we expect to have doses available for 300,000 patients in total within the next few months.”

REGN-COV2 is a combination of two monoclonal antibodies and was “designed specifically to block infectivity” of the virus that causes

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Trump returns from Walter Reed, White House backs FDA vaccine guidelines

The White House has reportedly backed away from a battle with the U.S. Food and Drug Administration (FDA), which has been advancing a timeline for a coronavirus vaccine that suggested an approval wouldn’t happen before Election Day.

The FDA has said it will need two months of observation in late-stage trials of any coronavirus vaccine in order to consider an emergency use authorization — an objective that conflicted with President Donald Trump’s desire to have an inoculation by early November. However, the White House signed off on the new guidelines Tuesday afternoon, backing away from a potential standoff that had worried health experts.

Trump, fresh from a stint in the hospital after being diagnosed with COVID-19, re-ignited the political debate over a vaccine timeline, putting him at odds with the FDA. In a video Monday evening, Trump also said that “vaccines are coming, momentarily” — even as FDA guidelines suggest

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Regeneron asks FDA for emergency authorization of its Covid-19 antibody therapy that was given to Trump last week

Regeneron says it has applied to the US Food and Drug Administration for emergency use authorization for its experimental monoclonal antibody therapy, the same antibody cocktail given to President Donald Trump Friday after he was diagnosed with the virus.



a woman preparing food in a kitchen: New York state based biotech company, Regeneron is working on an antibody therapy to treat, and possibly prevent, Covid-19.


© Regeneron
New York state based biotech company, Regeneron is working on an antibody therapy to treat, and possibly prevent, Covid-19.

The biotechnology company confirmed it had submitted the application for the authorization in a statement on its website Wednesday night.

“Under our agreement with the U.S. government for the initial doses of REGN-COV2, if an EUA is granted the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution,” the statement said. “At this time, there are doses available for approximately 50,000 patients, and we expect to have doses available for 300,000 patients in total within the

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