Business · 25/10/2007Updated: 10/17/2026 · 1 min read
FDA Publishes Draft Bioequivalence Recommendations for Industry
Summary
The FDA has released draft and revised draft product-specific bioequivalence recommendations, providing guidance on designing BE studies to support ANDA submissions, and making these recommendations available on the FDA website.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →