Policy & Regulation
Former agency officials now representing industry worry that a deregulatory bent could be driving "Simple Reform" plan to merge all medical product and clinical research inspectorates and that specialist expertise gained in 2017 "Program Alignment" initiative will be reversed.
MediNatura expands recall to include all lots of both ReBoost and ClearLife nasal sprays after microbial contamination and yeast or mold were found. Firm in 2021 challenged homeopathic drug oversight change from policy in place since 1988.
Only taking inflation into account, the European Commission’s new cost estimate of between €1.48bn to €1.8bn per year, when adjusted for inflation, results in a total very similar to the original €1.2bn estimate.
Sunscreen products industry and public health advocacy groups have been critical that FDA has not approved a new filter since 1999 even as countries in Europe and other regions allow using numerous additional ingredients in sunscreens.
Self-care solutions such as OTC drugs and wearables can save over 725,000 lives a year, argues a new report published by Reckitt and health insurance firm BUPA.
The tilt toward approval extended beyond patients and advocates to clinicians, professional societies and industry.
While no doubt welcome, yet another delay to the EU Deforestation Law and suggestion for another review next year could mean a “never-ending” regulatory exercise that creates uncertainty for manufacturers selling products containing or having been made using materials like palm oil, soya and wood.
A round up of the latest people moves in Europe: ANEFP names president; Pharma Deutschland makes board changes; Salus shakes up management.
UK consumer healthcare industry association, PAGB, suggests improvements that could help accelerate Rx-to-OTC switch in the country.
A new cohort of “techno-enthusiasts” who are highly susceptible to misinformation and inappropriate self-care decisions are undermining Italy's responsible self-medication model, finds a report by Italian self-care industry association, Assosalute, and independent researcher Censis.
Negative growth in global OTC market sales volume means that “as an industry, we're not doing good enough,” argues Opella’s Asia Pacific, Middle East and Africa (AMEA) head, Carol-Ann Stewart, in this exclusive feature interview.
In the second part of a special Self-Care Week episode of Over the Counter, HBW Insight speaks to PAGB CEO Michelle Riddalls about what the association is doing to promote self-care.
OMUFA reauthorization and directions for FDA to provide reports on monograph program and guidance on improving chances for OTC switch applications included in recent stopgap spending bill to end federal government shutdown.
“It’s not good enough just to provide products anymore, we need to create a service and a holistic approach to products,” argued Bayer Consumer Health's Northern Europe general manager, Mike Knowland, speaking at a recent panel event in the UK Parliament.
The studies reviewed by BMJ researchers failed to account for the fact that the association between in utero exposure to paracetamol and autism and ADHD in childhood “might be driven by familial genetic and environmental factors.”
But the Senate’s reduction would not be as much as the House of Representatives and President Trump proposed earlier this year, which is likely a win for the agency.
Scientific literature on potential link between prenatal acetaminophen exposure and neurological conditions “now includes FDA’s most recent epidemiological review” completed in May saying research results “insufficient to support a causal association.”
EllaOne manufacturer Perrigo tells HBW Insight that Community Pharmacy England's decision to offer free emergency contraception is "the right move for women" but also "makes pharmacy training and sex education more important than ever."
Norway's Medical Products Agency has rejected claims that misuse of OTC ibuprofen is linked to its availability for purchase in outlets other than pharmacies.
EU legislation aimed at controlling at source emerging pollutants such commonly used OTC analgesics like ibuprofen and diclofenac and “forever chemicals” like perfluoroalkyl and polyfluoroalkyl substances (PFAS) edges closer to adoption.