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US FDA Not Missing Assessment Goals, But Guidance Reminds That It’s Possible

 
• By Derrick Gingery

New Q&A guidance also states that its near-term focus for resources will be on coronavirus and some other conditions.

FDA Approved typed words on a vintage typewriter
Guidance addresses potential for user fee goal misses and virtual advisory committee meetings. • Source: Shutterstock

US Food and Drug Administration staff continue to meet user fee goal dates for product reviews, but stakeholders worry that delays are imminent given the substantial agency resources now devoted to the coronavirus pandemic.

Multiple sponsors and others agree with the FDA's statement that application decision goals remain on track. But stakeholders seem to...

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