ANDAs: Pre-Submission Facility Correspondence (PFC) Related to Prioritized Generic Drug Submissions
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- Опубліковано 5 гру 2022
- Updated enhancements to the PFC program include modified criteria for FDA to assess and act on priority ANDAs (originals, supplements, and amendments) within 8 months of the date of ANDA submission.
- Наука та технологія
