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US FDA Talking Tough On ANDAs, Says Extensions On Complete Responses Need Justification

 
• By Derrick Gingery

But most generic sponsors already give reasons for needing more time to respond to a complete response letters, so the status quo may not change despite the new guidance.

Guidance Word In Wooden Cube
There are plenty of reasons to receive an extension to the CR response deadline, including an inability to obtain reference product samples for bioequivalence testing. • Source: Shutterstock

US Food and Drug Administration officials may want to use new draft guidance to strike a more authoritative tone about extensions of ANDA complete response letter deadlines, but sponsors may not see much change from current practices.

The draft guidance, released 28 September, suggests that the agency may no longer “liberally” grant extension requests. The number...

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