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Regulatory Reform › Food and Drug Administration (FDA) › Food and Drug Act

Akin Gump Strauss Hauer & Feld LLP

Citizen Petition Calls on FDA to Rethink Refined Carbs

Akin Gump Strauss Hauer & Feld LLP on

Last week, former Food and Drug Administration (FDA) Commissioner David Kessler submitted a citizen petition urging FDA to revoke the generally recognized as safe (GRAS) status of refined carbohydrates used in industrial food...more

Jones Day

FDA Announces Proposed Rule Regarding Laboratory Developed Tests

Jones Day on

The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more

Faegre Drinker Biddle & Reath LLP

FDA issues final rule clarifying its “intended use” regulations for pharmaceuticals and medical devices

Faegre Drinker Biddle & Reath LLP on

The FDA issued a final rule (RIN 0910-A147) on August 2, 2021, to clarify its “intended use” regulations for pharmaceutical products and medical devices — 21 CFR §201.128 (drugs) and 21 CFR §801.4 (devices). The final rule...more

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