Ireland is balking at proposed tougher medical device regulations in the European Union, a major voice of opposition as member states work to hash out a final law.
The European Union began looking for a solution to vaccine instability earlier this year, and is now nearing the end of its search. A decision is expected next month, after which the EU will commit $3 million to support development of the vaccine temperature stability project.
Medical device regulatory reform in Europe faced another setback this week. A European Parliament committee has once again tabled a vote on tougher new regulations, putting it off for the second time since July.
Denmark wants any new medical device regulations in Europe to phase out a chemical used to soften plastic.
Biogen Idec has taken steps to provide a strong and durable fortress around intellectual property for its potential blockbuster Tecfidera in the European Union, but the effort is going to require additional time.
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.