Business · 02/04/2024Updated: 10/17/2026 · 1 min read
FDA Announces Final Guidance for Electronic Submission of Expedited Safety Reports
Summary
The FDA has released a final guidance for industry on submitting expedited safety reports from IND-exempt bioavailability/bioequivalence studies, building on a draft issued in August 2022.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →