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Comments to the FDA Transparency Task Force

Coukell A, Avorn J, Kesselheim AS, Nissen S, Psaty BM, Ross JS, Turner EH, Dickersin K, Caplan AL, Mann H, Maschke M, Pew Prescription Project - Food and Drug Administration (FDA)

Policy Interactions

| June 2009

Regulation and Clinical Evidence

Summary:

The FDA should adopt a presumption that safety and efficacy data submitted in drug applications should be made publicly available at the earliest possible time, including clinical study reports and FDA reviewer analyses, to enable independent scientific evaluation and strengthen the quality of agency decisions.

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