Firms operating in the EU given six months to evaluate all OTC drugs containing chemically synthesized APIs for presence of nitrosamines, a probable human carcinogen. The order from EMA comes with a review of ranitidine underway after nitrosamine NDMA was detected in a number of OTC and Rx drugs.
Marketing authorization holders in the EU should review all their OTC drugs containing chemically synthesized active pharmaceutical ingredients for the possible presence of nitrosamines and test all products at risk, the European Medicines Agency has requested.
The agency says the evaluation – which also applies to branded and generic prescription drugs – is necessary in light...
In a major milestone for the EU’s pricing and reimbursement landscape, the European Commission has published the first ever, much anticipated, joint clinical assessment report.
In this episode of the Over the Counter podcast, HBW Insight speaks to Kerry's RDA senior manager of immune and joint health, Sonja Nodland, about the opportunity for innovation that postbiotics represent for the consumer health industry.
Weak demand for virus-blocking nasal sprays since the pandemic has left Austrian biotech Marinomed with mounting debts. The company has applied for restructuring proceedings with an Austrian court in an attempt to secure its future.
Perrigo aims its new SolpaOne high-strength paracetamol effervescent at UK pharmacists, who now have expanded powers as part of the UK government's Pharmacy First initiative.
Court order dismisses claims against Perrigo and Joseph Papa, its former CEO, with prejudice. Settlement also bars any claim against plaintiffs and class members, “whether arising under state, federal, common or foreign law,” alleging liability for losses.
In this episode of the Over the Counter podcast, HBW Insight speaks to Kerry's RDA senior manager of immune and joint health, Sonja Nodland, about the opportunity for innovation that postbiotics represent for the consumer health industry.
Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
