News & Analysis as of

Technology Comment Period Food and Drug Administration (FDA)

Goodwin

Designating a Platform Technology: FDA’s Long-Awaited Draft Guidance

Goodwin on

In newly released Draft Guidance from the U.S. Food and Drug Administration (FDA) entitled, Platform Technology Designation Program for Drug Development, the FDA addresses its new designation program for platform...more

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

2023 ITC Section 337 Year in Review: Analysis & Trends: The Public Interest Impact – Considerations from AliveCor and Masimo

The year 2023 was marked by two landmark Commission determinations resulting in exclusion orders and cease and desist orders against a popular consumer wearable—the Apple Watch. both investigations focused on health...more

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