Just because the use of a substance in a cosmetic product, in this case prostaglandin-derivative methylamide-dihydro-noralfaprostal, has a physiological effect does not mean it's a medicinal product by function, advises the Advocate General of the Court of Justice of the EU in a recent opinion. While the opinion does not bind the CJEU to any decision, it may impact discussions elsewhere with regards to these substances, for example in the US.
“A medicinal product by function must have a beneficial effect on human health, and it is insufficient that the product merely modifies physiological functions,” advised the Advocate General of the Court of Justice of the EU in a recent opinion.
“Rather, such effects must be appreciable, significantly affecting the metabolism, and be genuinely designed for such a purpose taking into...
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.
