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European Union

Latest Headlines

Latest Headlines

Ireland resists tougher EU device regulations

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.

European Union prepares to back vaccine stability project

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.

Europe risks more delays on device reg reform

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 EU ban on chemical used in device manufacturing

Denmark wants any new medical device regulations in Europe to phase out a chemical used to soften plastic.

Biogen Idec taps brakes on EU launch of oral MS drug Tecfidera

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.

EU team wants medical device safety data posted online

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.

Industry swats EU proposal for U.S.-style device regulation

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.

Lundbeck anti-binge drinking drug gets EU OK

In a boost for struggling Lundbeck, and perhaps for college campuses, the European Union has approved its anti-binge drinking drug Selincro.

Irish effort explores stem cell treatments for diabetic complications

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.

EU notified bodies accused of improperly competing for device business

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.