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Under the terms of a revised mutual trade agreement between Switzerland and the European Union (EU), Swiss conformity assessment bodies may now certify medical devices and diagnostic products manufactured in countries outside the EU and European Economic Area (EEA).
Australia’s Therapeutic Goods Administration and New Zealand’s Medicines and Medical Devices Safety Authority have issued a draft rule on advertising of therapeutic products.
Worried about the potential for deadly diseases in animals to infect humans, the European Commission Dec. 22 implemented an amendment to a 2002 rule governing the use of animal byproducts not intended for human consumption.
A Canadian court’s invalidation of a key patent held by Pfizer could open the door to the manufacturing and marketing of atorvastatin tablets, a generic version of Pfizer’s blockbuster cholesterol-lowering drug, Lipitor.
A European generic trade group expressed doubts over the validity of a new briefing report released by the International Alliance of Patients’ Organizations (IAPO), saying the report fails to clearly address the science behind manufacturing a biosimilar, or follow-on biologic.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has concluded that the manufacture of medical devices containing Di(2-EthylHexyl) Phthalate (DEHP)-plasticized polyvinyl chloride (PVC) can be successfully phased out over time if manufacturers adhere to the provisions of the European Union’s Medical Devices Directive (MDD).
Swedish firm Straumann recently reported that its oral regenerative product company, Biora AB, had received an FDA warning letter informing the firm that its dental bone grafting materials have been placed under a U.S. import alert.
Drug companies will increasingly outsource their clinical trials in the coming years, with "many top pharmaceutical companies" expecting to do up to 65 percent of their clinical trials abroad, according to the "Outlook 2007" survey by the Tufts Center for the Study of Drug Development (CSDD).
A bipartisan group of House and Senate lawmakers have reintroduced legislation from the last congressional session that would allow limited importation of prescription drugs.