Regulatory Developments September 2021

Table of Contents
Regulatory Developments
September 2021

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Learn about recent draft guidances as of August 2021, including drug distribution security and labeling recommendations.

GUIDANCES

Type Title Status Date

Clinical - Medical

Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials

Final

8/06/2021

Pharmaceutical Quality, Chemistry, Manufacturing, and Controls (CMC)

Development and Submission of Near Infrared Analytical Procedures

Final

8/06/2021

Clinical - Antimicrobial

Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis Guidance for Industry: Draft Guidance for Industry

Draft

7/28/2021

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

Final

7/22/2021

Food Contact Substances (FCS), Food; Color Additives, Contaminants, Ingredients

Guidance for Industry: Use of Recycled Plastics in Food Packaging (Chemistry Considerations)

Final

7/15/2021

Premarket, User Fees, New Animal Drug Application (NADA), Target Animal – Effectiveness, Antimicrobial Resistance

Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs

Final

7/14/2021

Export, Import, Investigational Use

FDA Oversight of Food Products Covered by Systems Recognition Arrangements

 

7/12/2021





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