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The FDA is taking a hard look at ways to bring early-stage device trials back to the U.S., hoping to reverse a decade-long trend that has seen companies moving them overseas. Read More
Sponsors of Class II and Class III medical devices in China may bypass the need for clinical trials if they can show that the product is equivalent to a product listed in the country, new guidance says. Read More
Manufacturers of interventional cardiovascular devices may benefit from holding their first clinical trials in Europe, a clinical research organization advises. Read More
Sponsors of Class II and Class III medical devices in China may bypass the need for clinical trials if they can show that the product is equivalent to a product listed in the country, new guidance says. Read More
Sponsors of Class II and Class III medical devices in China may bypass the need for clinical trials if they can show that the product is equivalent to a product listed in the country, new guidance says. Read More
Drugmakers could see their wait time to begin clinical trials in Brazil cut by more than a third under a proposed regulation calling for protocols to be reviewed in their entirety, rather than in stages, as is the current policy. Read More
Sponsors are being encouraged to participate in an FDA pilot program aimed at designing and validating regulatory tools for use in developing new technologies. Read More