JD Supra

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

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 mandated increased ...
Food Safety News

FDA updates Food Code for the 50 states

The U.S. Food and Drug Administration has published the 2022 Food Code Supplement. The Supplement updates the 2022 Food Code with recommendations from regulatory officials, industry, academia, and ...
Regulatory Affairs Professionals Society

Therapeutic equivalence: FDA finalizes guidance on TE evaluations

The US Food and Drug Administration (FDA) on Monday finalized guidance on its approach to making therapeutic equivalence (TE) ...
RAPS

FDA issues long-awaited final NDC rule

The US Food and Drug Administration’s (FDA) widely anticipated final rule on national drug codes (NDCs) was published on Wednesday. The rule, which will take effect on 7 March 2033, replaces the ...
C&EN

How will FDA changes reshape drug approval in 2025 and beyond?

Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change. The 20% ...