US FDA Wants Authority To Mandate Minor Post-Approval Quality Changes

Legislative proposal in FY 2020 budget request wouldn't necessarily reduce number of complete response letters, but ability to require reports and postmarket changes on quality issues might eventually create more flexibility during initial product reviews.

The US FDA wants more enforcement authority over quality corrections that may not necessarily prevent approval, but still are necessary.

Agency officials want the ability to require specific changes or quality updates from sponsors after product approval to ensure the issues are resolved. In FDA's

US FDA Wants Authority To Mandate Minor Post-Approval Quality Changes

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