FDA Seeks Input on Use of AI/ML Technologies in Pharmaceutical Manufacturing
Summary
The FDA has reopened its Request for Information (RFI) for its Discussion Paper on the use of AI in drug manufacturing. The FDA originally issued the Discussion Paper on March 1, 2023, and the comment period was set to end on May 1, 2023, but stakeholders now have until November 27, 2023, to submit feedback. The FDA specifically requests input regarding what types of AI systems should be used in drug manufacturing, aspects of the current regulatory framework that may affect the implementation of AI in drug manufacturing, what guidance would be helpful, and common practices for validating and maintaining self-learning AI models that should be included in best practices, among other topics.
Impacted Sectors
Additional Information
© 2025 Akin Gump Strauss Hauer & Feld LLP. All rights reserved. Attorney advertising. This document is distributed for informational use only; it does not constitute legal advice and should not be used as such. Prior results do not guarantee a similar outcome. Akin is the practicing name of Akin Gump LLP, a New York limited liability partnership authorized and regulated by the Solicitors Regulation Authority under number 267321. A list of the partners is available for inspection at Eighth Floor, Ten Bishops Square, London E1 6EG. For more information about Akin Gump LLP, Akin Gump Strauss Hauer & Feld LLP and other associated entities under which the Akin Gump network operates worldwide, please see our Legal Notices page.