Herder M, Doshi P, Wallach JD, Graham JE, Lexchin J, Lemmens T, Ross JS, Gonsalves G, Persaud N, Lurie P, Naci H, Jones M, Jefferson T, Alexander GC, Turner EH, Mayo-Wilson E, Miller JE, Hemkens LG, Healy D, Jureidini J, Li T, Dickersin K, Kesselheim AS, Bruckner T, Reed T, Davis C - Food and Drug Administration (FDA)
- Policy Interactions
- Regulation and Clinical Evidence
Summary:
The FDA should complete and expand its Clinical Study Report pilot project by making public disclosure of clinical study reports mandatory for all approved drugs, as transparency of these company-generated trial documents is essential for identifying underreported safety and efficacy information
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