News & Analysis as of May 18, 2025

Food and Drug Administration (FDA)

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FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products

Sterne, Kessler, Goldstein & Fox P.L.L.C. on 1/15/2025

FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s safety, effectiveness, or...more

Report on Research Compliance Volume 16, Number 12. In This Month's E-News: December 2019

Health Care Compliance Association (HCCA) on 11/22/2019

Report on Research Compliance 16, no. 12 (December 2019) - NIH is seeking comment on a proposed policy for data management and sharing, as well as two related guidance documents that together seek to “promote effective and...more

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Public Comment › Data Management › Food and Drug Administration (FDA)

FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products

Report on Research Compliance Volume 16, Number 12. In This Month's E-News: December 2019

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