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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
Companies filing premarket approval applications for companion diagnostics may explain the clinical significance and clinical cut-off of their products using a summary of the clinical results for the corresponding drug product, recent technical guidance from Japan’s Pharmaceuticals and Medical Devices Agency says. Read More
Sponsors of device clinical trials should carefully examine the demographic distribution of study participants at various points during the study, the FDA says in final guidance published Wednesday. Read More
Implantable heart devices improve the chances of survival across racial groups, a study published in Tuesday’s Journal of the American College of Cardiologists concludes. Read More
The FDA has released a three-point action plan aimed at encouraging more diverse patient participation in medical device and drug clinical trials. Read More