The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) is posting an informational, pre-recorded webinar entitled “CVM Draft Guidance for Industry Documents #253 and 254: Good Manufacturing Practices and Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products (ACTPs).”
CVM recently issued two draft guidance documents on good manufacturing practices and donor eligibility for ACTPs. The webinar will provide information and examples on current good manufacturing practices 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Part 2: Draft guidance #253 Good Manufacturing Practices for ACTPs
Part 3: Draft guidance #254 Donor Eligibility for ACTPs
The webinar will remain available on the website as a resource for developers of ACTPs. Stakeholders can submit any questions to FDA-CVM-Animal-Biotechnology-Feedback@fda.hhs.gov.
CVM is also accepting public comments on both draft guidance documents until November 22, 2021, to ensure that we are able to consider comments before drafting final guidance documents; however, comments on guidance documents are welcome at any time. To submit comments electronically to the docket, visit https://www.regulations.gov and type FDA-2021-D-0399 in the search box for draft Guidance for Industry #253 and FDA-2021-D-0401 for draft Guidance for Industry #254.