Amarin may submit up to two proposed communications annually to FDA about unapproved use of its triglyceride-lowering drug Vascepa, and the agency must respond with any concerns within 60 calendar days.
FDA’s settlement of the Vascepa (icosapent ethyl) off-label marketing case is another important development in pharmaceutical and medical device industry First Amendment disputes that experts say may put additional pressure on FDA to revise its approach to off-label promotion.
The settlement with drug manufacturer Amarin Corp. PLC includes an optional preclearance provision for future communications about unapproved uses...
The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.
Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it.
To succeed in medtech, investors must focus on patient outcomes. Gilde Healthcare says involving patients boosts product effectiveness, access and market success — making it a smart strategy in today’s strained healthcare systems.
MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”
Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.
MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”
The UK government’s blueprint to deliver an NHS "fit for the future" was released on July 3.
