Zdrowie i gospodarka · 04/06/2013
Availability of Masked and De-identified Non-Summary Safety and Efficacy Data; Request for Comments
The Food and Drug Administration (FDA) is seeking public comments from interested persons on the proposed availability of de- identified and masked data derived from medical product applications. Improving the efficiency and effectiveness of medical product development is a national priority. The ability to make available de-identified and masked clinical and preclinical data derived from marketing applications could make an important contribution to that goal by providing scientific data that may be of value in the generation of new knowledge to facilitate innovation in the development and evaluation of critically needed medical products. The contribution of patients who participate in clinical trials should be maximized for the benefit of society. The Agency invites comments on the issues to be considered with regard to such availability and on any limitations that should be placed on the availability of these data.