FDASIA Study Mandates Focus On Performance, But Could Slow Reviews

Advocates for the agency worry that while each of the performance assessments seems reasonable individually, together the reports could burden staff to the point of pulling some from application reviews or other tasks to help complete them.

Congress and the public should get an updated and extensive look at FDA performance over the next few years thanks to the many studies included in the FDA Safety and Innovation Act, although the additional work may tax agency personnel.

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