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Life Sciences › Decision-Making Process › Food and Drug Administration (FDA)

Foley Hoag LLP

Loper Bright's Implications for the Food and Drug Administration and Regulated Industry

Foley Hoag LLP on

Under the Chevron doctrine, FDA and other agencies had significant flexibility to set policy where Congress left a gap or failed to speak clearly when enacting legislation—a common occurrence given the at-times sparse...more

McDermott Will & Emery

FDA Establishes CDER Center for Clinical Trial Innovation (C3TI)

McDermott Will & Emery on

On April 15, 2024, the US Food & Drug Administration (FDA) announced the establishment of the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI will serve as the central support...more

Axinn, Veltrop & Harkrider LLP

FDA Tackles AI . . . and Other Digital Health Technologies

Axinn, Veltrop & Harkrider LLP on

FDA announced on October 11, 2023 that it is creating a new Digital Health Advisory Committee to provide guidance to FDA on issues relating to digital health technologies ("DHTs"), including artificial intelligence,...more

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