News & Analysis as of

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FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products

FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s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

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

What is a Streamlined Reexamination Request (SRR)?

One way that reexamination advantageously differs from other administrative post-grant review processes is the absence of word or page counts as a limiting factor in presenting the challenge, here substantial new questions of...more

Orrick, Herrington & Sutcliffe LLP

CFIUS Proposes Filing Fees

To further implement the Foreign Investment Risk Review Modernization Act of 2018 (“FIRRMA”), the Committee on Foreign Investment in the United States (“CFIUS”) has issued proposed regulations that would require parties to...more

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