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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. Truly, these are complex considerations.

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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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FDA Issues First Injunction of its Product Safety Rule

XTalks

The company has agreed to stop production until it takes remedial action and complies with the Federal Food, Drug, and Cosmetic Act. Related: FDA Announces Slow Phase-Out of Certain PFAS Chemicals Used in Food Packaging.

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FDA Proposes to Harmonize the Quality System Regulation with ISO 13485

FDA Law Blog

Mullen — On February 23, 2022, FDA published in the Federal Register a proposed rule that would replace the Quality System Regulation (QSR), at 21 C.F.R. Part 820, with a newly named Quality Management System Regulation (QMSR). ISO 13485, while largely duplicative to the QSR, is not a perfect fit with other existing FDA regulations.

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In the News: October 2021 Regulatory and Development Updates

Camargo

The 21 st Century Cures Act generated a good deal of excitement and interest when it added a section called “ Utilizing Real World Evidence ” to the Food, Drug, and Cosmetic Act (Section 505F). Batch steps include filter drying, milling, and packaging. FDA Guidance Addresses Real-World Evidence Data Standards.

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Pet Food Institute Proposes Modernization of Pet Food and Treats Regulation

FDA Law Blog

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled.

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HP&M is Pleased to Welcome Lisa Baumhardt (Senior Medical Device Regulation Expert) and Sophia Gaulkin (Associate) to the Firm

FDA Law Blog

Baumhardt , MS, MJ, MT(ASCP), RAC, FRAPS, has joined the firm as a Senior Medical Device Regulation Expert, and that Sophia Gaulkin has joined the firm as an Associate. Baumhardt advises clients on complaint handling, MDRs, Quality System Regulation compliance and enforcement matters. Hyman, Phelps & McNamara, P.C. (“HP&M”)