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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 Aug. 20. Read More
Citing industry concerns, the FDA has reversed plans for a proposed voluntary presubmission process that would have allowed sponsors to get reviewer feedback before submitting an investigational device exemption application. 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
Medtech companies could see an increase in hostile takeover attempts and other forms of mergers during the remainder of 2014, as M&A activity heats up and companies look to complete product portfolios, a new report by Pricewaterhouse Coopers concludes. The group offers some advice for companies facing corporate change. Read More