GenBioPro, which markets a generic version of the medical abortion product, may pursue litigation in a more favorable jurisdiction than the Mississippi district court where the case had been proceeding. Senators ask HHS to consider filing its own suit to enforce federal preemption of state laws, lifting REMS restrictions and having FDA issue an EUA for misoprostol.
A legal ruling on whether US Food and Drug Administration policy preempts state laws restricting access to medication abortion has been delayed with GenBioPro Inc.’s decision to drop its suit challenging Mississippi’s laws.
GenBioPro filed a notice with the US District Court for the Southern District of Mississippi on 18 August that it...
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.
US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.
Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.
Too many “uninformative” drug trials fail to justify the excessively high prices of many medicines, while there is too much evidentiary uncertainty in European pricing and reimbursement systems, warned Anja Schiel from Norway’s NOMA.
