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AI in Support of Regulatory Decision Making

AI in Support of Regulatory Decision Making

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Roundtable to discuss the response of the Pistoia Alliance to the FDA draft guidance on AI

As you may know, in January of this year the US FDA issued a draft guidance “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products“.  The FDA is inviting comments to the new document, due on April 7th 2025.

 

  • We at the Pistoia Alliance would like to submit a response from our organization, ideally, coordinated with multiple stakeholders from our industry.  This, of course, in no way prevents you from making individual comments or responses on behalf of your companies.
  • We would like to share our thoughts in a round-table event. This event will be online on March 4th 2025 leaving us sufficient time to respond to the agency.
  • We are working internally on the draft response and intend to share it with all interested parties before the roundtable event in March. If you have any specific comments that you would like us to include, please contact vladimir.makarov@pistoiaalliance.org.  We will accept contributions before March 4th and for a limited time after.
  • We would like to identify like-minded people to champion this proposal, so please feel free to forward this note to your colleagues.
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