University of Kentucky anesthesiologist Raeford Brown says problem with transmucosal fentanyl regulation isn’t the REMS – it's that the products are approved at all.
The problems with continued misuse of transmucosal immediate release fentanyl products is not with the US FDA’s Risk Evaluation & Mitigation Strategy – but rather with the availability of the products at all, one of the members of FDA’s Anesthetic & Analgesic Drugs Advisory Committee that reviewed the TIRF REMS says in an email to the Pink Sheet.
“After five years of assessing the positions of the Agency, past mistakes, and the current state I am certain that...
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.
