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Rulemaking Process Food and Drug Administration (FDA) Compliance

King & Spalding

FDA Issues Two Guidances For the Device Q-Sub Process

King & Spalding on

CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR - On May 29, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center...more

Mintz - Health Care Viewpoints

FDA Continues Push to Improve Food Labeling Practices in the United States

In September 2022, former President Biden convened the White House Conference on Hunger, Nutrition, and Health, during which the White House introduced its National Strategy on Nutrition and Health (National Strategy). The...more

Davis Wright Tremaine LLP

FDA's Definition of "Healthy" … Updated Just in Time for New Year's Resolutions

After years of talk, the U.S. Food and Drug Administration in mid-December 2024 at last finalized an updated definition of the implied nutrient content claim "healthy." The original definition of "healthy" dates back to the...more

Venable LLP

Event in Review: The Modernization of Cosmetics Regulation Act of 2022

Venable LLP on

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the biggest change to the scope of the U.S. Food and Drug Administration's (FDA) regulatory authority over cosmetics since 1938. ...more

Health Care Compliance Association (HCCA)

Bucking History, ORI Deputy Denies Requests For Misconduct NPRM Comment Extension

Report on Research Compliance 20, no. 12  (December 2023) In a move that is unprecedented in recent memory, a federal agency has denied a request to extend the comment period on a substantive proposed rule, turning down a...more

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