A court order directing the US Food and Drug Administration to restore a webpage for the clinical trial diversity action plan guidance could lead to reinstatement of other information removed from the agency’s website in recent weeks.
US FDA Diversity Action Plan And Sex Differences Webpages Restored: Will Others Follow?
A federal judge granted Doctors for America’s motion for a temporary restraining order directing the FDA and CDC to restore information removed from the agencies’ websites to comply with a presidential executive order targeting “gender ideology extremism.”
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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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FDA testing of 95 benzoyl peroxide products due to concerns about elevated benzene detected by third-party testers found 90% with undetectable or extremely low benzene levels.
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Kim Kardashian lifestyle company SKIMS buys back rights to SKKN by Kim from Coty, Inc., which had purchased a 20% interest in the brand in 2020 for $200m. Separately, NYX Professional Makeup partners with Warner Bros. to launch the “A Minecraft Movie” collection.
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Chinese consumers are now routinely taking supplements for a variety of health reasons, helping to drive up sales of the Swisse Plus+ brand by 20% in 2024.
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US FDA Commissioner nominee Martin Makary is being embraced by industry, and Senate Democrats, as a more traditional pick than other Trump Administration nominees, but the Make America Healthy Again agenda still is clearly coming to the agency.