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Sponsors of companion diagnostics should submit applications to the FDA simultaneously with the drug product submission to improve the chances that the test on which the treatment relies is available when the drug is approved, an FDA final guidance says. Read More
Concerns about safety and efficacy data from a U.S. clinical trial, insufficient patient follow-up and the questionable culling of data from a European patient registry sank the Ablatherm-HIFU system for treatment of low-risk prostate cancer during a Wednesday FDA advisory panel meeting. Read More
Manufacturers of in vitro diagnostics and low-risk medical devices could have an easier time registering their products in Brazil, thanks to a pair of resolutions proposed by Anvisa. Read More