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Filing Requirements › Draft Guidance

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FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products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FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s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

Skadden, Arps, Slate, Meagher & Flom LLP

As US Antitrust Agencies Double Down on Merger Enforcement Approach, New Deal Strategies Emerge

Skadden, Arps, Slate, Meagher & Flom LLP on

Key Points - - New draft merger guidelines reflect the aggressive approach that has defined merger enforcement in the Biden administration, including novel theories of harm. - Proposed changes to HSR notification will make...more

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