FDA Archives - Mediarabe

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

October 14, 2020

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

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

October 13, 2020

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Partnership will develop and validate unique in vitro/in silico models for oral cavity products

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)

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

October 13, 2020

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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)

The Houston Chronicle:
FDA Shows President Trump Backbone On COVID Vaccine

The Food and Drug Administration guidance requiring two months of safety testing for the COVID-19 Emergency Use Authorization was just issued. This is important. Two months is not

IQVIA Joins FDA to Advance COVID-19 Understanding at Community Level through COVID Active Research Experience (CARE) Project

October 13, 2020

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IQVIA™ (NYSE: IQV), in scientific partnership with the U.S. Food and Drug Administration, will provide agile analytics from IQVIA’s CARE Project COVID-19 registry to support better understanding of how people in the community are affected by exposure to the coronavirus. IQVIA’s research will show what symptoms individuals experience, the length and severity and whether any medications or vitamin supplements they are taking affect the severity of their coronavirus symptoms.

The CARE Project is open to U.S. based residents who think they may have been exposed to the coronavirus, regardless of whether they have been diagnosed with COVID-19, including people who have continued with everyday life and may have been exposed. The project was established to advance understanding of COVID-19 as experienced in community settings.

The registry was launched in April 2020 and can be accessed at www.helpstopcovid19.com. Over three months, registrants are periodically asked to provide information

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

October 10, 2020

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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 a

FDA Panel: All Thumbs Down for Amphetamine Product Meant to Deter Abuse

October 9, 2020

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An FDA advisory committee voted unanimously Thursday that the risks of a novel amphetamine designed to deter abuse outweighed the benefits, concluding it may in fact be misused and could be even more dangerous than conventional stimulant medications for attention deficit-hyperactivity disorder (ADHD).

The panel also voted 19-2, with two abstentions, that drugmaker Arbor Pharmaceuticals did not adequately address the safety of AR19 (amphetamine sulfate), with many panelists noting that the drug appeared safe when administered orally, but that high levels of talc and polyethylene oxide in the drug’s composition could be toxic if taken through snorting or injection.

The joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee also concluded with a 15-8 vote that Arbor did not adequately demonstrate AR19 would deter intravenous use, and voted 19-4 that it did not adequately demonstrate it would deter intranasal use.

In fact,

FDA Commissioner Shares Requirements for COVID-19 Vaccine Approval

October 8, 2020

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Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

FDA experts evaluate three main areas for all vaccines, including for COVID-19: safety, effectiveness, and manufacturing quality.
Before a COVID-19 vaccine is approved, the FDA will review safety and effectiveness data from at least one well-designed and -performed clinical trial that shows data that are “clear and compelling.”
The FDA is looking for a COVID-19 vaccine that has a minimum of 50% efficacy but is hoping for higher.
The FDA is requiring a “very robust” program to continue to look at safety data after a COVID-19 vaccine is approved, as well as an “aggressive” postmarketing assessment program.

This transcript has been edited for clarity.

John Whyte, MD, MPH: You’re watching Coronavirus in Context. I’m Dr John Whyte, chief medical officer at WebMD. Today I am joined by Dr Stephen Hahn. He’s the commissioner of the US Food

Regeneron asks for emergency FDA approval for COVID-19 antibody treatment

October 8, 2020

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Oct. 8 (UPI) — Biotechnology company Regeneron has requested emergency use authorization from federal regulators for a COVID-19 antibody treatment.

The REGN-COV2 treatment is a combination of two antibodies that’s designed to “block infectivity” of the SARS-CoV-2 virus that causes COVID-19.

“The two potent, virus-neutralizing antibodies that form REGN-COV2 bind non-competitively to the critical receptor binding domain of the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population,” the company said in a statement.

Regeneron, which asked the Food and Drug Administration for the emergency authorization, said it has doses available for 50,000 patients and will have enough for another 300,000 in the coming months.

“If [emergency use authorization] 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,”

FDA Updates Health and Personal Hygiene Handbook for Food Employees

October 8, 2020

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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;

FDA Reaffirms Commitment to Safety, Security of its Public Health Laboratories

October 8, 2020

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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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