The FDA used its new National Priority Voucher pathway to grant an expedited review and approval to USAntibiotics’ extended‑release amoxicillin, the first clearance under the program. The decision — announced by FDA Commissioner Martin Makary — prioritized a U.S. domestic supplier for an antibiotic perceived as critical to supply‑chain resilience. The National Priority Voucher program was designed to accelerate reviews for drugs tied to U.S. ‘national interests’ and can compress review timelines to as little as one to two months. The move has prompted debate over policy trade‑offs between onshoring essential medicines and concerns from critics who say the program could be politically influenced and shift FDA priorities. Clarification: The National Priority Voucher grants an expedited review timeline to incentivize domestic manufacturing of medicines deemed critical to national security and supply chains.
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