Regulatory Developments October/November 2021

Table of Contents
Regulatory Developments
October/November 2021

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Learn about recent draft guidances as of September 2021.

GUIDANCES

Type Title Status Date

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

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

Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products

Draft

9/23/2021

Pharmaceutical Quality

Questions and Answers on Quality Related Controlled Correspondence Guidance for Industry: Draft Guidance for Industry

Draft

9/20/2021




*WOULD YOU LIKE TO COMMENT ON A GUIDANCE?


If you or your AAPS Community would like to submit comments, please contact Maria Nadeau. She will coordinate your input on behalf of AAPS.