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August 22/29, 2007

Posting FDA New Drug Application Reviews

Author Affiliations

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

JAMA. 2007;298(8):863-864. doi:10.1001/jama.298.8.863

To the Editor: In their Commentary, Drs Psaty and Charo1 discuss how the Food and Drug Administration (FDA) has responded “in part” to the recommendations by the Institute of Medicine (IOM) on drug safety. In Table 2, they list 25 specific IOM recommendations alongside the FDA's responses. Item 4.12 stands out as the only item to which the FDA responded “not accepted.” That item recommended that the FDA post all New Drug Application (NDA) review packages on the FDA's Web site, a suggestion that has been made in the past.2 The FDA response reads “Since 1998, FDA has committed to post all new NDA and BLA [biologics license application] original approval packages, but has not had sufficient resources to post all supplement reviews.”3

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