To better handle the growth of technologies intended to reduce the need for animal testing for regulatory decisions, a US Food and Drug Administration Science Board subcommittee suggests the agency establish a central office to oversee so-called new alternative methods (NAMs) in the commissioner’s office.
Animal Testing Alternatives Need Central Office At US FDA, Science Board
Slow adoption of alternatives to animal testing in the current decentralized regulatory framework.
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HBW Insight speaks to AESGP director general Jurate Švarcaite about what's on the agenda for the upcoming 61st AESGP Annual Meeting, which will take place in Warsaw, Poland, between 2-4 June. Highlights include the role of prevention in self-care, discussions about how regulators will ensure the competitiveness of European industry on the world stage and incoming changes to sustainability legislation.
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Notice published on 21 March is a word-for-word copy, other than different dates, of a document published on 24 January, Kennedy says the ACNU final rule’s effective date is delayed until 27 May, two months later than the initial delayed effective date.
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FDA’s OMUFA facility fees for FY2025, due on 2 June, increase nearly $2,400 to $37,556 for OTC monograph drug manufacturers and $2,200 to $25,037 for contract manufacturers. Overall target OMUFA fee total is just short of $36.47m, up from $32.25m for FY2024.
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“Overall, no unexpected/new data or findings” were presented to Germany's Expert Committee for Prescription in the most recent Rx-to-OTC switch application for sildenafil (25mg and 50mg), according to medicines regulator BfArM, resulting in a third rejection in three years.
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Counterfeit beauty products cost the US industry an estimated $3bn in 2023, says a trade expert during the Personal Care Products Council’s Beauty Collective Summit.
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Cosmetic companies should conduct audits to identify products that will be required to disclose fragrance allergens and begin the work of adjusting labels, particularly for smaller packaging, says a director at Registrar Corp., during a 12 March webinar on MoCRA and labeling.
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Cosmetics companies brace for the impact of Trump administration tariffs as industry experts seeing an opportunity for an exemption urge stakeholders to reach out to lawmakers. The issue was discussed during PCPC’s recent Beauty Collective Summit.