Regulatory Developments August 2021

Table of Contents
Regulatory Developments
August 2021

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

GUIDANCES

Type Title Status Date

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

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

Final

7/15/2021

CVM GFI #261 - Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs

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

Final

7/14/2021

FDA Oversight of Food Products Covered by Systems Recognition Arrangements

Export, Import, Investigational Use

Draft

7/12/2021

Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide (Revised): Guidance for Industry

N/A

Final

7/9/2021

Premarket, Animal Cell-Based Products

 

Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol: Guidance for Industry and Food and Drug Administration Staff

Final

7/9/2021

Center for Tobacco Products

Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised)

Final

7/9/2021




*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.