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Devicemakers may need to redesign scores of products and change their sterilization methods if the Environmental Protection agency goes through with plans to classify ethylene oxide as carcinogenic when inhaled by humans. Read More
The FDA is ordering manufacturers of power morcellators to add a black box warning to the devices and telling consumers the products are unsafe in almost all instances. Read More
The British government is looking to speed new drugs to market and provide faster patient access to medicines, an initiative that some industry experts say should include reforms of the UK’s healthcare reimbursement body. Read More
Australia and New Zealand have abandoned plans for a joint drug and device regulatory authority, although both countries say they will continue to cooperate on mutually beneficial regulations. Read More
The American Clinical Laboratory Association and American Medical Association are promising an all-out fight to stop the FDA from requiring premarket applications for high-risk laboratory-developed tests. Read More
Device and diagnostics makers would have to submit all clinical trial data to the federal government — including data for products never approved by the FDA — under a massive, proposed expansion of data collection. Read More
The FDA is seeking a court order to force a retired dentist in South Dakota to pull the laser devices he manufacturers from the market, but the defendant maintains he has the right to sell the devices through a private membership association. Read More
Manufacturers of low- and moderate-risk devices will soon be able to register their products in Australia based on conformity certificates issued by European notified bodies, under a government action plan unveiled Oct. 14. Read More