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Filing Requirements Data Management Regulatory Requirements

Sterne, Kessler, Goldstein & Fox P.L.L.C.

FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products

FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s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

Skadden, Arps, Slate, Meagher & Flom LLP

CFIUS’ Final Rules: Broader Reach, Narrow Exceptions and Foretelling Future Change

On January 13, 2020, the U.S. Department of the Treasury (Treasury), on behalf of the Committee on Foreign Investment in the United States (CFIUS or the Committee), issued two sets of final regulations implementing the...more

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