FDA Commissioner Martin Makary outlined a transformative 'New FDA' initiative at BIO 2025 aiming to expedite drug approvals through a pilot National Priority Voucher program. This program enables certain drug developers addressing US national health needs to receive review vouchers cutting approval times from typical 10-12 months to 1-2 months. Enhanced communication with sponsors and evaluation of redundant processes are also focal points to improve regulatory efficiency and maintain scientific rigor. The initiative reflects the FDA's commitment to modernization amid concurrent workforce optimizations.