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FDA's Strategy Document on Facilitating Chemistry, Manufacturing, and Controls Readiness for Products With Accelerated Clinical Development

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 Pr...

PDF versionFederalRegister.gov
Department of Health and Human Services
Food and Drug Administration
  1. [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:

  • Federal eRulemaking Portal:https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
  • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

  • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked, and identified as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2026-N-7232 for “FDA's Strategy Document on Facilitating Chemistry, Manufacturing, and Controls Readiness for Products With Accelerated Clinical Development.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

  • Confidential Submissions: To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see docket number, Date, or access the information at: https://www.gpo.gov/​fdsys/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT:

Tanya Clayton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4506, Silver Spring, MD 20993-0002, 301-796-0871, or Phillip Kurs, Center for Biologics Evaluation and Research, Food and Drug Administration, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

Products with accelerated clinical development activities often face challenges in expediting chemistry, manufacturing, and controls (CMC) development activities to align with the accelerated clinical timelines. Overcoming such CMC challenges often requires additional interaction with FDA during product development and the use of science- and risk-based regulatory approaches so that the clinical benefits of earlier patient access to these products can be realized. Since April 2023, FDA has implemented a CMC Development and Readiness Pilot (CDRP) to facilitate expedited CMC development of CDER- or CBER-regulated products under an IND application and on an accelerated clinical timeframe. In addition, on September 10, 2025, FDA cosponsored a public workshop hosted by the Duke-Margolis Center for Health Policy titled “Lessons Learned from the CDRP Program.” Regulators and industry representatives discussed the current barriers to expedited CMC readiness, and shared ideas on how practices like those employed in the pilot could alleviate these barriers. The pilot and the workshop fulfilled PDUFA VII commitments related to facilitating CMC ( printed page 46444) readiness for products with accelerated clinical development.

Based on lessons learned from the Agency's experience with submissions involving accelerated clinical development, especially those through the pilot, the discussions during the September 10, 2025, workshop, and other public input, this Strategy Document outlines the specific activities FDA has undertaken or intends to undertake to facilitate CMC development for products with accelerated clinical development timelines. These include: continuing to provide opportunities for enhanced communication and the application of risk-based, scientific, and regulatory strategies to sponsors with a Breakthrough Therapy, Fast-Track, or Regenerative Medicine Advanced Therapy Designation; and providing regulatory flexibilities as described in CDER's existing MAPP 5015.13 and CBER's newly published flexibilities for cell and gene therapies (see the announcement at link: https://www.fda.gov/​vaccines-blood-biologics/​cellular-gene-therapy-products/​flexible-requirements-cell-and-gene-therapies-advance-innovation and the guidance at https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​chemistry-manufacturing-and-controls-flexibilities-developing-human-cellular-and-gene-therapy).

The Strategy Document will be made available on the following FDA web page:

Grace R. Graham,

Deputy Commissioner for Policy, Legislation, and International Affairs.

[FR Doc. 2026-14898 Filed 7-22-26; 8:45 am]

BILLING CODE 4164-01-P

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91 FR 46443

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“FDA's Strategy Document on Facilitating Chemistry, Manufacturing, and Controls Readiness for Products With Accelerated Clinical Development,” thefederalregister.org (July 23, 2026), https://thefederalregister.org/documents/2026-14898/fda-s-strategy-document-on-facilitating-chemistry-manufacturing-and-controls-readiness-for-products-with-accelerated-cli.