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US FDA’s Standard Application Assessment Makes A Comeback

 
• By Derrick Gingery

After years where many more applications received priority assessments than standard assessments, in FY 2022 the difference narrowed.

FDA headquarters
Priority review voucher user fees will decrease nearly 14% in FY 2024. • Source: Shutterstock

Suggestions the US Food and Drug Administration’s standard application assessment may be losing relevance appear to have been premature.

In Fiscal Year 2022, the most recent data available, standard assessments reversed a widening gap from the number of priority assessments that the FDA undertakes.

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