Policy & Regulation
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.”
Sleep, pain, allergy and women's intimate health among the categories that the UK Department of Health and Social Care would like to see manufacturers submit Rx-to-OTC switch applications for.
Electronic product information should be “fully operational” within four years after the entry into force of the revised EU pharma legislation and should precede the phasing out of paper leaflets, proposes the Inter-Association Taskforce (IATF) on ePI. Once the new system is up and running, ePI should be implemented across the EU in a harmonized way, with all EU member states adopting the same standard, it says.
HBW Insight asks consumer health experts for their views on the trends that will shape the market in 2025.
“The SVA has missed an opportunity to make an important contribution to patient safety and to strengthening personal responsibility,” commented Pharma Deutschland deputy general manager Elmar Kroth.
Critics of requirements that sponsors first demonstrate conventional labeling wouldn’t support an OTC switch before submitting proposals for ACNU switches and for simultaneous availability of Rx formulations of approved ACNU switches likely look to delay as chance to convince the agency to strike one or both components of the final rule.
White House expected to name Sara Brenner, chief medical officer for in vitro diagnostics at CDRH and a veteran of first Trump administration, as acting commissioner, but lack of a formal announcement is creating uncertainty. New executive orders on telework and the senior executive service also could impact agency staff.
A recent ASA case involving an ad for vape products shows that marketers shouldn’t assume that professional online networks like LinkedIn are any different to other social media platforms when it comes to UK advertising codes.
Today, Germany's switch committee, the SVA, will consider an application for exemption from requirement for sildenafil in 25mg and 50mg strengths. This is the third time the switch has been put to the committee, which has rejected it twice before.
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.
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."
FDA Office of Nonprescription Drugs explains in its proposed commitment letter for fiscal years 2026-2030, based in part on suggestions by stakeholders, that it will heighten its attention to collecting those fees.
The Washington State Department of Ecology publishes ‘Interim Policy on Lead in Cosmetics’ which provides safe harbor options for cosmetic products struggling with the 1ppm limit under the state’s Toxic Free Cosmetics Act, while the department gathers information under a newly opened rulemaking to ‘identify a feasible approach to regulating lead in cosmetic products.’
Biovanta’s products relieved symptoms faster than OTC drugs available under FDA monograph, according to clinical trial by brand owner Applied Biological Laboratories. Chief scientific officer Nazlie Latefi said the results were “greatest decreases to date in overall illness severity using clinically validated measures and comparable study design.”
A recent Kenvue survey shows that an overwhelming majority of UK pharmacists believe many health issues could be prevented through better self-care.
Namandje Bumpus' departure means there is no obvious, internal candidate to serve as acting commissioner when President-elect Donald Trump takes office in January and the Senate works to confirm a new leader.
Latest regulatory goals update also includes April as target date for final rule on exemptions from IND clearance for clinical trials to evaluate food, dietary supplements or cosmetics and May for an NPRM would recognize N-acetyl-L-cysteine as a lawful dietary ingredient.