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  6. FDA CVM Public Webinar on the Development of ACTPs
  1. Center for Veterinary Medicine (CVM) Animal Biotechnology Products Resource Center

FDA CVM Public Webinar on the Development of ACTPs

The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) posted an informational, pre-recorded webinar entitled “CVM Draft Guidance for Industry Documents #253 and 254: Good Manufacturing Practices and Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products (ACTPs).” (Note that this webinar was recorded prior to finalization of GFIs #253 and #254 but the information contained in it remains consistent with the final guidances.)

In 2022, CVM issued two draft guidance documents on good manufacturing practice and donor eligibility for ACTPs. The webinar provides information and examples on current good manufacturing practice related to preserving cellular function and integrity, ensuring consistency of the process and product, preventing contamination, selecting appropriate donors and preventing transmission of disease.

There are three parts to this webinar:

Part 1: Introduction 

Part 2: Draft guidance #253 Good Manufacturing Practices for ACTPs 

Part 3: Draft guidance #254 Donor Eligibility for ACTPs 

 

Stakeholders can submit feedback and questions to FDA-CVM-Animal-Biotechnology-Feedback@fda.hhs.gov. 

If you have questions about an animal biotechnology process or product, please contact the agency at AskCVM-Biotech@fda.hhs.gov. For information on other product types or for all other general inquiries, contact AskCVM@fda.hhs.gov. 

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