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  4. FDA CBER OTP Public Listening Meeting: Leveraging Knowledge for Facilitating the Development and Review of Cell and Gene Therapies - 09/18/2025
  1. OTP Events, Meetings, and Workshops

Meeting | Virtual

Event Title
FDA CBER OTP Public Listening Meeting: Leveraging Knowledge for Facilitating the Development and Review of Cell and Gene Therapies
September 18, 2025

Date:
September 18, 2025
Time:
10:00 a.m. - 4:00 p.m. ET

The FDA Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) hosted a virtual public listening meeting to solicit perspectives from cell and gene therapy (CGT) manufacturers and other stakeholders on leveraging prior knowledge and experience to facilitate product development and application review.

During the meeting, speakers shared how internal prior and public knowledge can be leveraged to help advance development and regulation of CGT products. Speakers in all sessions were asked to consider the following questions when crafting their remarks, and were encouraged to discuss examples specific to the session of interest and recommendations from a CMC, nonclinical, or clinical perspective:

  • What types of data and information are Sponsors willing to share that will be useful for advancing CGT product development and regulatory review?
  • What data leveraging is possible between external partners (such as CMOs, CDMOs, and licensees) while considering various aspects of product lifecycle?
  • How can data and information be effectively integrated and leveraged across multiple disciplines to enhance the development, manufacturing, and safety assessment of CGT products? 
  • What mechanisms could be used to facilitate data and information sharing?

View the recording from this public listening meeting.

 

Submitting Electronic or Written Comments

In addition to holding the virtual public listening meeting, FDA has opened a docket and is accepting electronic or written comments. Electronic or written comments on this listening session must be submitted no later than 11:59 p.m. ET on October 17, 2025.

Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic comments in the following way:

  • Federal eRulemaking Portal: visit http://www.regulations.gov and type FDA-2025-N-2218 in the search box. For assistance in submitting electronic comments, please see regulations.gov/help. Comments submitted electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Division of Dockets Management, 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-2025-N-2218 for “FDA CBER OTP Public Listening Meeting: Leveraging Knowledge for Facilitating the Development and Review of Cell and Gene Therapies.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov.  Submit both copies to the Division of Dockets Management.  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 80 FR 56469, September 18, 2015, or access the information at:  http://www.fda.gov/regulatoryinformation/dockets/default.htm.

For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, FDA-2025-N-2218, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

About the OTP Public Listening Meeting

This event was held to meet an FDA commitment that is part of the seventh authorization of the Prescription Drug User Fee Act (PDUFA VII). By the end of fiscal year 2025, FDA will convene a public meeting to solicit the perspective of cell and gene therapy manufacturers on how individual sponsors might leverage internal prior knowledge and public knowledge, including Chemistry, Manufacturing, and Controls, nonclinical, and clinical knowledge, across therapeutic contexts in order to facilitate product development and application review. Input from this meeting will be used to inform development of a draft guidance on this topic.

Contact

For questions regarding the public workshop, please contact OTPPublicEventsandWorkshops@fda.hhs.gov.

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