FDA Commissioner Martin Makary outlined an ambitious vision for a "New FDA" emphasizing streamlined drug approvals, integration of AI and big data, and enhanced partnership with industry. At the BIO International Convention, Makary announced a pilot Commissioner’s National Priority Voucher program allowing expedited 1-2 month review timelines for drugs supporting U.S. national health interests, substantially shorter than the typical one-year timeline. He defended recent agency staffing cuts while highlighting efforts to reduce redundancies and improve morale. The program requires early submission of application components and close sponsor communication. Industry stakeholders have lauded these reforms as vital for competitiveness and patient access.