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Novartis has said that although it makes sense, from a business point of view, to consider merging with Aventis to rescue the French drugmaker from a hostile takeover bid, it would only move forward on negotiations if French regulators dropped their objections to the potential combination.
Eucomed, the European Medical Technology Industry Association, has submitted a proposal to the Medical Device Expert Group asking it to adopt the Medical Devices Directive (MDD) 93/42/EC, which will allow devicemakers to use elabeling as an alternative to paper leaflets.
Devicemakers will soon have a revised set of internationally harmonized codes for reporting adverse events, which will focus more heavily on cause types, according to Carol Herman, the standards director at the Center for Devices and Radiological Health.
Nearly equal average approval times for new biopharmaceutical products in the U.S. and the European Union (E.U.) suggest the FDA and the European Medicines Evaluation Agency (EMEA) are making progress toward their goal to harmonize their regulatory processes, according to a research study released this week.
Mentor received full European Union (E.U.) Class III CE Mark approval last week for its line of breast implant products, making it the second U.S. firm in a month to receive E.U. approval for silicone implants.
Inamed's silicone breast implants received Class III CE Mark approval and recertification in the European Union (E.U.) last week, a decision that is at odds with a recently upheld 11-year ban on the implants in the U.S.
Cordis has completed patient enrollment in a randomized study to pit its Cypher sirolimus-eluting stent against Boston Scientific's Taxus Express2 paclitaxel-eluting stent.
Even though European legal constraints on transferring personal data could have profound effects on U.S. drugmakers, few of them have become certified under a U.S.-European Union (E.U.) safe harbor agreement, perhaps because the pact's enforcement provisions are making them uneasy, according to industry experts.
The European Parliament’s Foreign Affairs Committee has given the thumbs up to the 10 countries slated to join the European Union (E.U.) in May, although some of them still have a lot of improvements to make.