CSMS 52132388PGAinformational

Conclusion of FDA’s 24/7 Drug Entry Review Pilot

Published Jun 10, 2022

Summary

FDA announced the conclusion of its 90-day Nationalized Drug Entry Review Pilot on June 11, 2022, ending 24/7 national drug entry admissibility reviews and shutting down the pilot's dedicated contact channels. FDA will analyze pilot data to assess potential improvements to the drug entry review process.

Summary is machine-generated at the linking layer for discovery only. Refer to the source bulletin for authoritative guidance.

CSMS 52132388 · full bulletin