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HHS officials highlighted progress in developing new Ebola diagnostics during a Wednesday House hearing, but acknowledged that more companies are looking for government support to move their products quickly to market. Read More
A study on the optimal length of dual antiplatelet therapy following implantation of a drug-eluting stent shows that 30 months is better than one year in preventing certain adverse outcomes. 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