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Innovation Food and Drug Administration (FDA) Compliance

Gardner Law

From Discretion to Regulation: FDA's New Path for LDTs

Gardner Law on

Earlier this year, we reported on the expected U.S. Food and Drug Administration (FDA) ruling concerning Laboratory Developed Tests (LDTs). The FDA has consistently shown a commitment to regulating LDTs. On May 6, 2024, the...more

American Conference Institute (ACI)

[Webinar] What New Dietary Ingredient Master Files Mean for Innovation & Compliance - May 27th, 1:00 pm - 2:00 pm EST

FDA first raised the concept of Master Files for dietary supplements in its 2016 revised NDI Guidance. The agency views master files as a tool to promote better compliance with NDI notification requirements. Ingredient...more

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