FDA Comments – No. FDA–2013–N–0271: Availability of Masked and De-identified Non-Summary Safety and Efficacy Data – June 2013

Harvard University’s Multi-Regional Clinical Trials Center (MRCT) submitted the following comments on FDA’s proposal, 78 Fed. Reg. 33421 (June 4, 2013), to make de-identified and masked clinical and preclinical data, from marketing applications submitted to FDA, available to external experts and others, as part of the Agency’s transparency initiative.

FDA proposes to make available to the public pooled data that have been sufficiently de-identified and masked (as to the drugs involved in the trial) in order to protect confidential commercial information, for analysis by the broader community.