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When A Sponsor Wants To Proceed On A COVID Product, US FDA Almost Never Says No

 
• By Derrick Gingery

Bob Temple tells the Pink Sheet that many of the drugs that sponsors are bringing forward have “not much evidence” of antiviral properties, “but it's still worth trying.” Jacqueline Corrigan-Curay emphasizes that even as FDA responds to the enormous coronavirus challenge, the agency's other work continues.

Coronavirus 2019-nCoV Blood Sample. Corona virus outbreaking. Epidemic virus Respiratory Syndrome. China
Senior FDA officials said in an interview that the agency has not stopped all non-coronavirus operations as a result of its pandemic response. • Source: Shutterstock

US Food and Drug Administration officials do not appear overly interested in tamping down the unprecedented interest in finding a treatment for the coronavirus, despite the enormous workload it is generating.

In an interview with the Pink Sheet, Robert Temple, FDA Center for Drug Evaluation and Research deputy center director for clinical science, said it is rare that proposals to test potential coronavirus treatments are turned away for lack of evidence, particularly

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Commission Taking ‘Due Account’ Of Scathing Report On EU Clinical Trial Bottlenecks

 
• By Vibha Sharma

A report by the European pharmaceutical industry criticizes the EU’s clinical trials framework, highlighting regulatory fragmentation, inefficiencies and the need for targeted reforms.

UK MHRA’s Clinical Trial Lead On Combined Reviews, The Notification Scheme & Increasing Diversity

 
• By Eliza Slawther

In light of the UK’s MHRA announcing a major overhaul of its clinical trial legislation, the agency’s deputy director for clinical investigations and trials Andrea Manfrin tells the Pink Sheet what sponsors can expect from the new regulation.

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 
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US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

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Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

FDA Use Of Artificial Intelligence Will Help US Retain Biotech Leadership

 
• By Sue Sutter and Derrick Gingery

At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.

US FDA Rare Disease Case Studies Provide Development Models For Sponsors

 
• By Laura Helbling

Sanofi’s Xenpozyme and Sentynyl’s Nulibry are the first two case studies the FDA is using to continue educating rare disease sponsors on best practices.