The US Food and Drug Administration’s view that it’s “rolling out the red carpet” for innovation in smoking cessation treatments isn’t shared by some stakeholders in the sector who instead suggest the agency’s pulling the rug out from under them.
US FDA Keeps Cessation As ‘Gold Standard’ For NRT Indication As Critics Question Its Worth
FDA’s OTC office director details a 2023 guidance as opening doors for NRT innovation at recent public meeting, but researchers and an industry executive note the most recent approval in the US for an innovative NRT was more than 20 years ago and say FDA isn’t allowing sufficient flexibility for approvals of new products or indications other than cessation related to quitting smoking.
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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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UK food toxicity committee says substantial exceedances of the Acceptable Daily Intake of turmeric - such as through excessive supplement use - represents a potential health risk to humans.
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The Expert Panel for Cosmetic Ingredient Safety issued a revised tentative amended report for p-phenylenediamine and related ingredients during its 171st meeting.
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FSA now aims to send the first recommendations for the authorization of CBD novel food products to UK government ministers in 2025, according to its most recent board meeting. The agency is closely scrutinizing trace THC levels and is planning to ban use of CBD food products by under 18s.