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FDA Commissioner Scott Gottlieb drew questions from lawmakers on device approvals as he laid out his early priorities in a House appropriations hearing Thursday, and announced that the hiring freeze on the agency had officially been lifted. Read More
China’s Food and Drug Administration received more than 350,000 medical device adverse event reports in 2016, an increase of 10 percent on the previous year. Read More
Grace Fu Palma, founder and CEO of Boston-based China Med Device, a firm specializing in commercialization and funding for U.S. medtech companies entering China, offers an update on CFDA’s clinical trial reform.Read More
The FDA is moving ahead with plans for the National Evaluation System for Health Technology (NEST) as one of its top CDRH priorities this year. Read More