CMS and FDA data showed prescriptions jumping while other fentanyl products were coming down.
FDA’s advisory committee review of the transmucosal immediate release fentanyl (TIRF) risk evaluation and mitigation strategy was a mixed bag of observations, recommendations, and opinions, but one thing was clear: Subsys made a bad impression on the panel.
The TIRF REMS has been viewed as a model of how other class-wide or shared REMS could work. The tone...
The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”
Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.
The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.
Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.
The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.
