Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability; Comment Request
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products." In accordance with its mission of protecting, promoting, and advancing public health, FDA's Center for Drug Evaluation and Research (CDER), in collaboration with the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Veterinary Medicine (CVM), the Oncology Center of Excellence (OCE), the Office of Combination Products (OCP), and the Office of Inspections and Investigations (OII), is issuing this draft guidance to provide recommendations to industry on the use of artificial intelligence (AI) to produce information or data intended to support regulatory decision-making regarding the safety, effectiveness, or quality for drug and biological products.
Abstract as published in the Federal Register.
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