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Sponsors wishing to test high-risk new drugs for the first time on human subjects are advised to undertake additional preliminary studies in some circumstances, under a new draft guideline from the European Medicines Agency (EMEA).
The European Society of Radiology (ESR) and the European Federation of Neurological Associations last month announced the launch of the Alliance for MRI to stop European Union (EU) legislation from inadvertently preventing the use of magnetic resonance imaging (MRI).
Japan has the "slowest, least transparent and most difficult regulatory system" of the major medical device markets, hurting developers of innovative, advanced-technology devices, a new report from the International Trade Commission (ITC) says.
Australia’s Therapeutic Goods Administration (TGA) has posted advice on its website for device firms transitioning to the international regulatory model adopted by the Global Harmonization Task Force.
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has drafted a proposal to introduce 11 new categories of consultative services aimed at helping manufacturers traverse the regulatory pipeline, according to Pacific Bridge Medical (PBM), a consulting group that focuses on Asia and Pacific Rim countries.
Hip, knee and shoulder joint replacements have been reclassified to ensure a higher level of scrutiny before they can be sold in the UK market, bringing that country into line with European Union requirements.
Now in its 15th year, the Global Harmonization Task Force (GHTF) should get serious about encouraging implementation of harmonized guidance documents and other efforts aimed at facilitating mutual recognition and product acceptance in the international marketplace, a U.S. Food and Drug Administration (FDA) official said.
Sixty-five percent of European healthcare opinion leaders who responded to a recent survey said they would like the European Union (EU) to develop a centralized regulatory authority for all member states, similar to the U.S. Food and Drug Administration, to handle market approval of all health technologies.
Sponsors wishing to test high-risk new drugs for the first time on human subjects are advised to undertake additional preliminary studies in some circumstances under a new draft guideline from the European Medicines Agency (EMEA).
The reinstatement of Merck’s Fosamax patent in Europe could spell trouble for generic firms who market their own versions of the
drug in that part of the world, according to A.G. Edwards & Sons.