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News Brief: More FDA Guidances for the New Year

by Walter Morris, PDA

The Northern Hemisphere with a digital grid over it like a dome against a black and green starry fieldOn January 6, the U.S. Food and Drug Administration (FDA) released more guidances of interest to the PDA community:

  • Draft Guidance: Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products
  • Final Guidance for Industry: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act
  • Final Guidance for Industry: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act

The draft guidance on the use of artificial intelligence (AI) for regulatory decision-making provides recommendations to sponsors and other interested parties on the use of AI to produce information or data intended to support regulatory decision-making regarding safety, effectiveness or quality for drugs. Specifically, this guidance provides a risk-based credibility assessment framework that may be used for establishing and evaluating the credibility of an AI model for a particular context of use.

The draft guidance follows a 2023 discussion paper issued by the FDA on the topic. PDA and a number of organizations commented on that paper and was covered in the PDA Letter in June of 2024. More details on this draft and how it compares to the discussion paper will be published in the PDA Letter shortly.

Comments on this draft guidance are due to FDA by April 7, 2025.

The two final guidances for bulk drug compounders describes policies for compounders who are not outsourcing facilities (503A) and those that are (503B). The two guidances finalize drafts that were issued by the Agency in December 2023 and replace previous final guidances of the same names issued in January 2017.

References

  1. Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products | FDA
  2. Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act | FDA
  3. Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act | FDA
  4. FDA/CDER Readying Draft Guidance on AI to Support Regulatory Decision-Making