Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA or Agency) is announcing the publication of FDA's Strategy Document on Facilitating Chemistry, Manufacturing, and Controls Readiness for Products With Accelerated Clinical Development (Strategy Document), which outlines actions FDA has taken and the Agency's plans for fiscal years 2026-2027 to facilitate chemistry, manufacturing, and controls (CMC) readiness for products with accelerated clinical development timelines. 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 its capability to facilitate CMC development for sponsors of CDER- and CBER-regulated drugs and biologics intended to diagnose, treat, or prevent a serious disease or condition where there is an unmet medical need. The actions described in the Strategy Document are based on lessons learned from FDA's experience with submissions for products on accelerated clinical development timelines as well as other public input.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2026-N-7232] ( printed page 46443) AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the publication of FDA's Strategy Document on Facilitating Chemistry, Manufacturing, and Controls Readiness for Products With Accelerated Clinical Development (Strategy Document), which outlines actions FDA has taken and the Agency's plans for fiscal years 2026-2027 to facilitate chemistry, manufacturing, and controls (CMC) readiness for products with accelerated clinical development timelines. 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 its capability to facilitate CMC development for sponsors of CDER- and CBER-regulated drugs and biologics intended to diagnose, treat, or prevent a serious disease or condition where there is an unmet medical need. The actions described in the Strategy Document are based on lessons learned from FDA's experience with submissions for products on accelerated clinical development timelines as well as other public input. DATES: The announcement of the strategy document is published in the Federal Register on July 23, 2026. ADDRESSES: You may submit either electronic or written comments as follows. Electronic Submissions Submit electronic comments in the following way:…
Citation: 91 FR 46443
