Learn about recent draft guidances as of September 2021.
Premarket, Chemistry, Manufacturing, and Controls (CMC), Current Good Manufacturing Practice (CGMP), New Animal Drug Application (NADA), Investigational New Animal Drug (INAD), Animal Cell-Based Products
Good Manufacturing Practices for Animal Cells, Tissues, and Cell- and Tissue-Based Products
Draft
9/23/2021
Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products
Pharmaceutical Quality
Questions and Answers on Quality Related Controlled Correspondence Guidance for Industry: Draft Guidance for Industry
9/20/2021
If you or your AAPS Community would like to submit comments, please contact Maria Nadeau. She will coordinate your input on behalf of AAPS.
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