Avoiding Drug Review Limbo

Given the increased number of missed user fee deadlines in the past few years, industry executives have some advice for FDA on how to could make those misses less painful for drug sponsors: communicate a revised goal date.

In cases where FDA misses a user fee review deadline, communicating a new target date for a decision—rather then leaving an NDA or BLA in limbo—would help restore credibility and predictability to the system.

Industry consultant Bruce Burlington, who worked for FDA before leaving in 1999 to head up regulatory affairs for Wyeth, discussed...

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