Policy & Regulation
Supplement and food product firms have until January 2027 and oral drug product firms have until a year later to stop using Red No. 3, FDA decides in approving 2022 petition filed by public health advocacy groups.
Former FDA commissioners Mark McClellan and Scott Gottlieb, former acting commissioner Janet Woodcock and current commissioner Robert Califf offered advice on successfully implementing reforms and preventing a mass exodus of FDA employees as inklings emerge that the Trump team is already engaged on this front.
Cavazzoni, who led the drugs center four-and-a-half years, decided on her own to retire at this time, sources said. The decision may have been a preemptive move knowing her time as head of CDER would have been limited, or at the very least highly challenging, under the new administration.
Australian government finds an insufficient body of new evidence to support Rx-to-OTC switch of erectile dysfunction drug sildenafil since it was last considered in 2020.
Business
A round-up of the latest European people moves: PAGB names new president; Enzymatica hires marketing & sales director; Marinomed strengthens supervisory board.
Bayer is investing $52m in its Lerma, Mexico manufacturing site, which the firm said will enable it to increase production of key OTC brands like Aspirin and Alka-Seltzer from 100m to 140m units by 2030.
Developed using Datair's Ambee climate data technology, Opella’s Pollen Passport presents users with an easy to use and interactive online visualization of air quality at holiday destinations across the world.
Bayer Consumer Health, the Global Self-Care Federation and the Business Council for International Understanding outline in a paper how industry can work with multilateral organizations, governments, financial institutions, and stakeholders to "recognize and champion self-care as a fundamental driver of global health progress."
Innovation & IP
Developed using Datair's Ambee climate data technology, Opella’s Pollen Passport presents users with an easy to use and interactive online visualization of air quality at holiday destinations across the world.
Australian government finds an insufficient body of new evidence to support Rx-to-OTC switch of erectile dysfunction drug sildenafil since it was last considered in 2020.
Bayer Consumer Health snaps up digital therapeutic Cara Care for its Precision Health business with an eye to developing its self-care capabilities.
Bayer Consumer Health shelves European launch of topical OTC onychomycosis treatment under its Canesten brand after a Phase III trial of the product - developed by Sweden's Moberg Pharma - failed to meet its primary endpoint.
Rx-to-OTC Switch
Australian government finds an insufficient body of new evidence to support Rx-to-OTC switch of erectile dysfunction drug sildenafil since it was last considered in 2020.
Final rule’s requirement that ACNU formulations also remain available as Rx generics could limit revenues for marketers of the nonprescription drugs while approvals of ACNU applications from studies with participants having drugs delivered to their homes may require marketers to limit distribution to direct-to-consumer without clearance for sales in retail stores.
Study completed in 2024 showed consumers using an online application accurately self-selected and safely used an Rx statin drug. An “ACNU” switch NDA would have to first show conventional OTC labeling won’t support proper self-selection and use.