'Real Challenge' To Improve OTC Monograph Program Without User Fees – FDA

FDA is weighing the potential benefits of, and drawbacks to, establishing user fees to support its OTC drug monograph program, opening a docket for comments and conducting a June 10 public meeting on the subject. Industry seems far from on board at present, and FDA also acknowledges that there could be downsides to a user fee program in addition to potential benefits for companies and consumers.

Industry has reservations about possible user fees to support FDA's OTC drug monograph activities, but the agency is fairly adamant that the program needs greater funding, particularly if it moves forward with a potential overhaul of the system to improve its functioning.

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Many small US and independent beauty brands are still unfamiliar with the Modernization of Cosmetics Regulation Act, as are owners of beauty brands based outside the US; the lack of education about the regulation is making many stakeholders at risk for non-compliance.

FDA Delays Cosmetic GMP Proposed Rule Until October 2025; Fragrance Allergen Labeling Targeted For January

 

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FDA Cosmetics Director Katz Retires After 22 Years; Manga To Lead OCAC On Acting Basis

 
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Linda Katz presided over a two-decade-long effort to boost FDA’s authority over cosmetic product safety during her time as director of the Office of Cosmetics and Colors. She will retire in January.

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Are Your Beauty Claims ‘Green’ Or Greenwashing?

 
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Guest authors Marcha Isabelle Chaudry, an attorney and founder of the Equity and Wellness Collaborative, and Rachel Raphael, partner at Morgan, Lewis & Bockius, LLP, write about the risks companies face in making claims in the realm of ‘green’ beauty, where an absence of a universal standard or definition for ‘green’ is creating confusion and in some cases, legal headaches.

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Linda Katz presided over a two-decade-long effort to boost FDA’s authority over cosmetic product safety during her time as director of the Office of Cosmetics and Colors. She will retire in January.