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.
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.
Oral pseudoephedrine decongestants marketed by Kenuve, Haleon and Opella, amongst others, are now only available with a doctor's prescription in France.
Pharmaceutical industry associations are united in their view that the revised EU Urban Wastewater Treatment Directive discriminates against medicines and cosmetics producers.
EMA's PRAC clarifies risk of high anion gap metabolic acidosis (HAGMA) in users of OTC paracetamol with new package leaflet and SmPC warnings.
The agency also will not expand the guidance categories that may be issued “for immediate implementation” without prior public comment, but more guidance documents could be issued in Q&A or bulleted formats, the agency said.
The incoming Trump Administration’s “Department Of Government Efficiency” has big plans for sweeping cuts to the federal bureaucracy and regulation. The US FDA likely will feel some effects, but could avoid the most damaging mandates.
Martin Makary prides himself on following the data, but some health policy experts said his positions sometimes stray from or distort the evidence, which could create trust issues.
Kenvue backs UK government legislation proposing to remove access to nicotine products, including vapes, to under 18s and ban their advertising and sponsorship.
Organizations representing APAC health and medicines regulators and the consumer health industry respectively have agreed to “recognize the importance of self-care as a fundamental pillar of health and wellbeing” and “affirm our dedication to advancing self-care as an essential component of Universal Health Coverage.”
The EU’s health nominee may not be as controversial as the recent US one, but the candidate being grilled has proved the least popular of the commissioner nominations with MEPs