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JNCI Journal of the National Cancer Institute 2006 98(13):884-885; doi:10.1093/jnci/djj285
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© Oxford University Press 2006.

NEWS

Report Hits FDA to Revamp Safety Oversight

Joel B. Finkelstein

The first 10% of the full text of this article appears below.

The Food and Drug Administration continues to feel pressure to revamp its safety surveillance systems after a critical federal review of postmarketing oversight failures.

A congressionally requested analysis from the U.S. Government Accountability Office found that the FDA lacked a consistent process for acting on postmarketing safety data and, in fact, restrained some results from being presented to decision makers. Agency critics recommend a multitude of fixes, including everything from minor repairs to a complete overhaul, but whether such changes will be made is unclear.

"Despite recent developments, the FDA . . . [Full Text of this Article]

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