Politico January 10, 2025
WEEKEND READ
This week, the Food and Drug Administration issued guidance documents concerning artificial intelligence in medical devices and drug discovery that highlight its focus on algorithm transparency. The documents offer nonbinding advice to the drug and medical device industries on technological advances.
Drug development: One draft guidance puts guardrails around AI models used to help create or support data submitted to prove a drug’s safety, effectiveness and quality.
The agency wants applicants to demystify their algorithms and provide specific details about what the models do, how they’re supposed to be used, how risky they are to patients, how well they perform and how companies plan to monitor them. It also asks companies to design and complete credibility assessments for...
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