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In Reply: Dr Tuttle and colleagues discuss the value of FDA reviews and supporting documents. The complexity of finding these documents¹ is further support for the need to improve the FDA Web site. A former FDA reviewer called for improving the accessibility, formatting, and navigability of the publicly available FDA reviews 5 years ago.² Unfortunately, little progress seems to have been made since then.

Dr Mathis and colleagues cite several examples of recent legislation creating requirements for posting FDA reviews related to pediatrics on the FDA Web site. While I fully support legislative efforts to improve the public availability of FDA reviews and supporting documents, the use of these reviews depends on (1) potential users' awareness that information contained within these documents may not be found elsewhere and yet may be valuable and (2) potential users' ability to find these reviews and the important information within them in a reasonable . . . [Full Text of this Article]

Alec B. O’Connor, MD, MPH
alec_oconnor@urmc.rochester.edu
Department of Medicine
University of Rochester School of Medicine and Dentistry
Rochester, New York

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Improving Access to FDA Reviews and Documents
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