Two Medical Device Draft Guidances Detail Thermal Effects, Q-Submission Process March 18, 2024 Comments on both guidances are due by May 14. Read More
Drug Shortages, Hatch-Waxman Amendments Lead FDA’s 2025 Legislative Agenda March 18, 2024 Amidst the ongoing legal fracas over march-in rights, the FDA wants to end Hatch-Waxman’s three-year exclusivity provisions. Read More