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The FDA has shared draft guidance on using AI for regulatory decisions in drug and biologic products.

The FDA has shared draft guidance on using Al for regulatory decisions in drug and biologic products

The FDA has released a draft titled “Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products”.

This document outlines key recommendations for using AI in regulatory decisions, ensuring safety, transparency, and accuracy in drug and biologic product evaluations.

Whether you’re in the pharmaceutical, biotech, or AI industry, this is essential reading to stay ahead in this evolving space.

What to expect:

  • Ethical considerations for AI use
  • Ensuring data integrity and reliability
  • Potential implications for future approvals

📥 Download the draft here:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-artificial-intelligence-support-regulatory-decision-making-drug-and-biological

#ResponsibleAI #FDA #Biotech #PharmaTech #AIRegulations

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