Business · 06/11/2017Updated: 10/17/2026 · 1 min read
FDA Releases Revised Draft Guidance for Pre-Submission of Facility Information for Prioritized Generic Drug Applications
Summary
The FDA is updating its draft guidance to reflect changes to the Federal Food, Drug, and Cosmetic Act resulting from the FDA Reauthorization Act of 2017, which impacts the pre-submission of facility information for generic drug applications.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →