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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.

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Industry Urged To Respond To EU Expectations On Using Animal Testing Alternatives

 
• By Eliza Slawther

The chair of a European Medicines Agency working group on reducing animal testing said that companies can provide “thoughts and suggestions” in relation to a review of its scientific guidelines on regulatory testing requirements and new approach methodologies.

Industry Benefits As EU CTIS Hits Global Data Sharing Milestone

 
• By Neena Brizmohun

The EU Clinical Trials Information System has achieved primary registry designation in the International Clinical Trials Registry Platform in a move that is expected to reduce regulatory burden for companies and help them lower compliance costs by aligning with publication requirements in medical journals.

Early Randomization Among Advice On How To Meet Both EMA & HTA Needs

 
• By Neena Brizmohun

Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.

E6(R3) Introduces Flexibility And Challenges To Clinical Trial Documentation

 
• By Vibha Sharma

The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.

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Industry Benefits As EU CTIS Hits Global Data Sharing Milestone

 
• By Neena Brizmohun

The EU Clinical Trials Information System has achieved primary registry designation in the International Clinical Trials Registry Platform in a move that is expected to reduce regulatory burden for companies and help them lower compliance costs by aligning with publication requirements in medical journals.

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Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.

Korea To Revise ‘Innovative Company’ Criteria Amid Calls From Foreign Industry

 
• By Jung Won Shin

South Korea announces planned revisions to a government scheme to designate "innovative" biopharma companies amid allegations of "discrimination" against foreign firms.