Learn about recent draft guidances as of August 2021, including drug distribution security and labeling recommendations.
Clinical - Medical
Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials
Pharmaceutical Quality, Chemistry, Manufacturing, and Controls (CMC)
Development and Submission of Near Infrared Analytical Procedures
Clinical - Antimicrobial
Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis Guidance for Industry: Draft Guidance for Industry
Investigation; Enforcement, Pharmaceutical Quality, Chemistry, Manufacturing, and Controls (CMC), Current Good Manufacturing Practice (CGMP)
Field Alert Report Submission: Questions and Answers Guidance for Industry: Guidance for Industry
Food Contact Substances (FCS), Food; Color Additives, Contaminants, Ingredients
Guidance for Industry: Use of Recycled Plastics in Food Packaging (Chemistry Considerations)
Premarket, User Fees, New Animal Drug Application (NADA), Target Animal – Effectiveness, Antimicrobial Resistance
Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs
Export, Import, Investigational Use
FDA Oversight of Food Products Covered by Systems Recognition Arrangements
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
To read the full content, please log in with your AAPS member username and password.
Sign InNot a member? Learn more and join today!
AAPS Newsmagazine helps pharmaceutical scientists excel in their jobs by providing current science, news, career advice, member recognition, AAPS offerings, and other valuable contemporary information.
Kristen Kalmann, Content Manager 2107 Wilson Blvd. Ste. 200 Arlington, VA 22201
Kira Krewson1-770-810-6982 View the Media Kit
AAPS Customer Service