FDA chief warns U.S. is losing ground to China in early drug development, calls for faster trial approvals

Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug applications process ...
National Law Review

New FDA Drug Reforms: Congress Extends Voucher Incentive, Clarifies Orphan Exclusivity and Provides Greater Transparency for Q1/Q2 Generic Approvals

Key Takeaways In legislation enacted on Feb. 3, 2026, Congress reauthorized the rare pediatric disease priority review voucher program, clarified the scope of orphan drug exclusivity (ODE) and ...