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November 25, 2009

Improving Access to FDA Reviews and Documents

JAMA. 2009;302(20):2204-2205. doi:10.1001/jama.2009.1726

To the Editor: The Commentary by Dr O’Connor1 highlighted the importance of using publicly available US Food and Drug Administration (FDA) review documents in conducting independent assessments of the therapeutic value of new drugs. Many trials submitted to the FDA were recently found to be unpublished 5 years after new drug approvals.2 Accordingly, the information that is easily available in the published medical literature is incomplete and potentially biased.

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