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Draft Guidance › Artificial Intelligence › Filing Requirements

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

FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products

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

FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s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

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

Key Considerations When Using AI Tools to Draft and File Documents with the USPTO

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

The use of Artificial Intelligence (AI) tools in practice before the United States Patent and Trademark Office (USPTO) is changing how practitioners prepare and submit documents. The USPTO’s recent Guidance on Use of...more

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