1. Pink Sheet

Accelerated Approval Decline? Too Early To Overinterpret US FDA Trend

 
• By Michael McCaughan

The US FDA is likely to end 2022 with noticeably fewer Accelerated Approvals granted than in recent years. But it is far too early to conclude that the agency is backing off the pathway – at least in spirit.

up and down percentage
• Source: Shutterstock

National media outlets have noticed an interesting data point regarding US Food & Drug Administration approvals in 2022: the use of Accelerated Approval appears to have dropped sharply.

First The Wall Street Journaland then the Associated Press highlighted a perceived change in FDA’s approach to Accelerated Approval in articles published early in December

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