FDA's Strategy Document on Innovative Manufacturing Technologies

The Food and Drug Administration (FDA or Agency) is announcing the publication of FDA's Strategy Document on Innovative Manufacturing Technologies (Strategy Document), which outlines specific actions FDA has taken and the Agency's plans for fiscal years 2023-2027 to facilitate the use of innovative manufacturing technologies. As part of the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures Fiscal Years 2023-2027 (PDUFA VII), FDA committed to advance the use and implementation of innovative manufacturing. The actions described in the Strategy Document are based on lessons learned from FDA's experiences with submissions involving advanced manufacturing technologies as well as public input.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.