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
Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products
Questions and Answers on Quality Related Controlled Correspondence Guidance for Industry: Draft Guidance for Industry
If you or your AAPS Community would like to submit comments, please contact Maria Nadeau. She will coordinate your input on behalf of AAPS.
Merck’s Covid Antiviral Gets WHO Backing for High-Risk Patients
Mental-Health Scars Stay With Survivors Long After Covid Battle
Biden Says Easing of Mask Rules by Governors Is ‘a Tough Call’
Is Covid Becoming Endemic? What Would That Mean?: QuickTake
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