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Opinion: Congress needs to update FDA’s ability to regulate diagnostic tests, cosmetics

STAT News

Congress is considering two measures that modernize tools the Food and Drug Administration uses to oversee two areas of its vast portfolio: diagnostic tests and cosmetics. While the stakes are different for each of these industries, the basic premise driving these measures is the same. Read the rest…

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Conference Notebook: ACI’s Cosmetics and Personal Care Products Conference

FDA Law Blog

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance.

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ACI’s Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products – West Coast Edition

FDA Law Blog

The American Conference Institute (“ACI”) is holding its 2nd West Coast Editionof its Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products from September 25-26 at the Le Meridien Delfina, Santa Monica, California. s John W.M. s John W.M. s John W.M.

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Will Modernization of Cosmetic Regulation Finally Happen?

FDA Law Blog

While FDASLA focuses on user fees and includes several other provisions regarding drugs and devices, it also includes provisions related to cosmetics. Efforts to update safety standards for cosmetics have been ongoing since 2013, with the proposed Personal Care Products Safety Act of 2021 being the most recent iteration prior to FDASLA.

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January 31, 2024: Improving the Public’s Understanding of the FDA, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday's PCT Grand Rounds, Susan Winckler of the Reagan-Udall Foundation for the FDA will present "Strategies for Improving Public Understanding of FDA and the Products It Regulates: Why Should We Care, and What Might We Do?" The Grand Rounds session will be held on Friday, February 2, 2024, at 1:00 pm eastern.

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FDA Designations for Rare Disease Products, Part 1

Camargo

The US FDA offers sponsors a variety of special designation programs to incentivize them to develop and deliver therapies to treat unmet patient needs, such as Fast Track Designation (FTD), Breakthrough Therapy Designation , and Qualified Infectious Disease Product Designation. Where is the regulation found? 21 CFR §814 Subpart H.

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Doctoring the Law: Congress May Let FDA Regulate the Practice of Medicine

FDA Law Blog

FDA , which held that that banning a single intended use of a specific device was inconsistent with the Federal Food, Drug, and Cosmetic Act’s (“FDC Act”) clear pronouncement that FDA cannot regulate the practice of medicine. This provision represents a complete shift in the way FDA is allowed to regulate products.