Business · 21/08/2009Updated: 10/17/2026 · 1 min read
FDA Proposes Electronic Submission Requirements for Postmarketing Safety Reports for Human Drug and Biological Products
Summary
The FDA is proposing to require electronic submission of postmarketing safety reports for human drug and biological products to improve the agency's systems for collecting and analyzing safety data, and to align with international standards.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →