OTP Guidance Webinar: Potency Assurance for Cellular and Gene Therapy Products

#1760000: OTP Guidance Webinar: Potency Assurance for Cellular and Gene Therapy Products

Description:	The FDA Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP) will host a virtual public webinar on Thursday, December 10, 2026, at 1:00 p.m. ET to discuss the recently finalized guidance, "Guidance for Industry: Potency Assurance for Cellular and Gene Therapy Products". This guidance provides recommendations for developing a science- and risk-based strategy to help ensure the potency of human cell and gene therapy products throughout the product lifecycle. OTP subject matter experts will present an overview of the final guidance and highlight key updates, including recommendations on integrating potency assurance into existing quality systems, expanded guidance on risk assessment, regulatory engagement pathways, and more. Meeting Logistics and Registration Date: Thursday, December 10, 2026 Time: 1:00 – 2:00 p.m. ET Location: Virtual — Microsoft Teams Registration: Free but required. Register at OTP Guidance WebinarExternal Link Disclaimer Registration is limited and will close once capacity is reached. FDA encourages early registration. For those unable to register, the webinar will also be broadcast live on YouTube. A link will be posted closer to the event date.  Submit a Question Questions may be submitted during registration or by email at OTPEvents@fda.hhs.gov. Please submit questions by November 18, 2026. Questions will not be taken during the live event. Please note that FDA cannot comment on specific investigational products, biologics applications, or draft guidance documents during the webinar. Questions that are out of scope or otherwise inappropriate will not be addressed. Due to time constraints, not all submitted questions may be answered.
More info:	https://www.fda.gov/vaccines-blood-biologics/otp-guidance-webinar-potency-assurance-cellular-and-gene-therapy-products-12102026

Description:

The FDA Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP) will host a virtual public webinar on Thursday, December 10, 2026, at 1:00 p.m. ET to discuss the recently finalized guidance, "Guidance for Industry: Potency Assurance for Cellular and Gene Therapy Products". This guidance provides recommendations for developing a science- and risk-based strategy to help ensure the potency of human cell and gene therapy products throughout the product lifecycle.

OTP subject matter experts will present an overview of the final guidance and highlight key updates, including recommendations on integrating potency assurance into existing quality systems, expanded guidance on risk assessment, regulatory engagement pathways, and more.

Meeting Logistics and Registration
Date: Thursday, December 10, 2026
Time: 1:00 – 2:00 p.m. ET
Location: Virtual — Microsoft Teams
Registration: Free but required. Register at OTP Guidance WebinarExternal Link Disclaimer
Registration is limited and will close once capacity is reached. FDA encourages early registration. For those unable to register, the webinar will also be broadcast live on YouTube. A link will be posted closer to the event date. 

Submit a Question
Questions may be submitted during registration or by email at OTPEvents@fda.hhs.gov. Please submit questions by November 18, 2026. Questions will not be taken during the live event.

Please note that FDA cannot comment on specific investigational products, biologics applications, or draft guidance documents during the webinar. Questions that are out of scope or otherwise inappropriate will not be addressed. Due to time constraints, not all submitted questions may be answered.

More info:

https://www.fda.gov/vaccines-blood-biologics/otp-guidance-webinar-potency-assurance-cellular-and-gene-therapy-products-12102026

Date added	Nov. 2, 2026, 3:29 p.m.
Source	FDA
Subjects	HealthCare Industry News PodCasts / Webcast / Webinar / eSummit / Virtual Event etc. Security Guidelines / Checklists etc
Venue	Dec. 10, 2026, midnight - Dec. 10, 2026, midnight