Policy & Regulation
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.
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.
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.
“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.
“The president has chosen a do-it-all-now strategy, recognizing that the midterm congressional elections are a little over a year away,” says CHPA CEO Scott Melville. “We're just 57 days into the second Trump administration, and we are experiencing lots of unexpected things.”
“Protecting the environment is a shared responsibility. It is unfair to expect only two sectors to fund wastewater treatment modernization and operation,” argues AESGP director general Jurate Švarcaite.
It wasn’t a quick decision for Xlear to accept DoJ attorneys’ offer to dismiss the case. “I want the I want the FTC to change its policy and its behaviors,” says Xlear president Nathan Jones.
Health and Human Services Secretary Robert F. Kennedy Jr. is moving FDA Chief Counsel Robert Foster to a new senior position as Chief Counsel for Food, Research, and Drugs at HHS. Hilary Perkins will become FDA chief counsel.
FTC under Chairman Andrew Ferguson is likely to be defined by less rules and guidance and a focus on enforcing laws already on the books, says BBB National Programs’ Exec VP, Policy, Mary Engle.
HBW Insight speaks to AdverCheck managing director James Walmsley about the rise of direct-to-consumer prescription drugs marketing in the UK, and its impact on the consumer healthcare industry.
Some FDA employees who were recently laid off by the Trump Administration are being called back to work, multiple sources confirmed to the Pink Sheet.
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.