Study examines high-risk therapeutic medical devices receiving FDA premarket approval

11 agosto 2015

Of high-risk therapeutic devices approved via the Food and Drug Administration Premarket Approval pathway between 2010 and 2011, there has been wide variation in both the number and quality of premarket and postmarket studies, with approximately 13 percent of initiated postmarket studies completed between three and five years after FDA approval, according to a study.
http://www.sciencedaily.com/releases/2015/08/150811132248.htm

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