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US FDA Coronavirus Response Features Three-Step Triage Process For Inquiries

 
• By Kate Rawson

Office of New Drugs Director Peter Stein outlines how his reviewers are prioritizing COVID-19 work, and how he is reallocating resources to the pandemic response.

COVID-19 SARS,Coronaviridae , SARS-CoV, SARSCoV, virus 2020 , MERS-CoV ,chinese virus 2019-nCoV

The US Food & Drug Administration is triaging COVID-19 treatment protocols and other coronavirus-related inquiries coming into the agency using a team led by the Division of Anti-Infectives as part of an unprecedented reallocation of personnel across the agency in response to the pandemic, Office of New Drugs Director Peter Stein said in an interview with the Pink Sheet.

The group, known as the “COVID Scientific Technical Triage Team,” is the forward-facing part of the Coronavirus Treatment Acceleration Program, which the agency launched via a website to prioritize work on coronavirus treatments. The triage team has a 24-hour response target to answer any inquiries from sponsors and other stakeholders

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US FDA Advisory Committee Misperceptions Abound … At HHS

 
• By Michael McCaughan

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.

US FDA Layoffs Hit Conflict-Of-Interest Screening For ODAC Meeting

 
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Screening for conflicts and finding the right expertise for a two-day Oncologic Drugs Advisory Committee meeting on four products has been complicated by the Trump Administration’s initial communications freeze and subsequent layoffs in CDER.

FDA Adcomms Are Back: Four Cancer Drugs, COVID-19 Vaccine Formulations To Get Reviews

 
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Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 
• By Neena Brizmohun

The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.

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EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
• By Eliza Slawther

The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.

Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
• By Neena Brizmohun

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.