FDA Commissioner Scott Gottlieb,M.D., vows to enhance clarity of Clinical Trial information

In a bid to ensure transparency and clarity in their drug approval decisions,  U.S FDA Commissioner Scott Gottlieb endeavors to undertake new drug innovation and Scientific progress by imparting information that facilitates research and curation of advanced treatments thereby relaying new medical technology.

U.S FDA Commissioner vows to ensure utmost patient care by exchanging information about product approvals. Keeping patients informed about the products they prescribe is also an ardent aspect of the mission. One of the ways where they are currently assessing information that better aware scientists, providers and patients is Clinical study reports.

FDA intends to commence a new pilot program to evaluate whether divulging certain information included within the CSRs  post the approval of a NDA enhances public access to drug approval information. Undertaking to post parts of the CSRs there were most crucial to the FDA’s evaluation of the safety and efficacy of the drug enumerating the protocol and amendments. FDA also seeks to elicit public feedback through a Federal  Register notice and docket for public comments. Another way by which they wish to augment their level of  transparency is by adding to FDA materials for future FDA drug approvals the ClinicalTrials.gov identifier number.

FDA is thus committed to assuring the safety, effectiveness and security of human and veterinary drugs, vaccines and other biological products for medical devices and human use.