European medical device regulations must become more transparent, and patients deserve the ability to access safety data from an online registry, researchers concluded in a recommendation published in the British Medical Journal .
A European Union proposal to establish a U.S.-style centralized approval process for medical devices is drawing condemnation from a major industry group as a step backward for both patients and the industry.
In a boost for struggling Lundbeck, and perhaps for college campuses, the European Union has approved its anti-binge drinking drug Selincro.
Researchers in Ireland will pursue preclinical trials to see whether stem cells derived from bone marrow can be used to treat a whole slew of diabetes-related complications.
A U.K. newspaper accuses some of the largely private entities that handle medical device approvals in the European Union of crossing the line by competing for business and offering regulatory advice on how to package products made elsewhere as locally manufactured.
Low vaccination rates against human papillomavirus (HPV) in Europe have regulators there urging all girls to get vaccinated against the sexually transmitted virus.
After 10 years of dwindling interest from medical researhcers, Europe is considering revising its rules on clinical trials. The European Commission is proposing a revision to the Clinical Trials Directive, and CRO groups have praised the idea.
A new report from a top U.K. health regulator concludes that implants made by France's now-defunct Poly Implant Prosthese rupture more easily, but didn't pose any long-term health risks to women who had them.
The European Parliament is proposing a sweeping change in the way devices reach the market there, a move that would institute the EU's first continental pre-market authorization system.
Biovest International's stock has risen by 15% on two pieces of news about its personalized cancer vaccine for the treatment of follicular non-Hodgkin's lymphoma, BiovaxID.