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On June 17, 2025, the U.S. Food and Drug Administration (FDA or the Agency) announced its new Commissioner’s National Priority Voucher (CNPV) program. Under the CNPV program, FDA may grant priority review to U.S. drug companies “aligned with U.S. national priorities” that could significantly expedite access to innovative therapies. General details about the CNPV program were made available in a press release, accompanying FAQ, and message by FDA Commissioner Makary posted on X, but more information is expected from the Agency.

On May 21, 2025, the U.S. Food and Drug Administration (FDA or the Agency) issued a notice on its FDA.gov website (FDA.gov Notice) describing how the Agency plans to help states and Indian tribes more effectively and efficiently develop proposals to import prescription drugs from Canada under section 804 (21 U.S.C. 384) of the Federal Food, Drug, and Cosmetic Act, for potential authorization by FDA. The FDA.gov Notice frames these plans as part of the Agency’s efforts to effectuate President Trump’s April 15, 2025 Executive Order, “Lowering Drug Prices by Once Again Putting Americans First.”

On March 5, 2025, Regulation 2025/327 (EHDS Regulation), creating a European Health Data Space (EHDS), was published in the European Union Official Journal (EU Official Journal), marking the end of the legislative process of the EHDS Regulation. This Advisory analyzes the final text of the EHDS Regulation, focusing on the key elements relevant to the secondary use of health data for Life Sciences companies.