FDA Commissioner Scott Gottlieb, M.D., on new steps FDA is taking to enhance transparency of clinical trial information to support innovation and scientific inquiry related to new drugs

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Scientific progress and new drug innovation don’t take place in a vacuum. The exchange of information that informs decisions to undertake research, invest in new scientific endeavors, and prescribe and use certain treatments effectively are a critical part of enabling the development and dissemination of new medical technology. Transparency related to this information can play a critical role in maximizing the public health value of the resulting innovations.

As part of our efforts to enhance transparency around our drug approval decisions, we’re exploring new ways the U.S. Food and Drug Administration can continue to build on its obligation to share information about product approvals. We’re especially focused on information that can improve patient care and better inform providers about the products they prescribe. One place where we are evaluating how we can release information that may better inform scientists, providers, and patients is clinical study reports (CSRs). Continue reading...

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