Discovery quotes (wave)1-5 Quotations of 189
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The underlying problem is that the FDA has little ability to enforce these commitments, short of withdrawing approval for the drug _ an outcome that may not serve the public health well. The great majority of post-marketing studies address safety issues, at least in part, so patients and physicians are denied critical safety information when these studies are not completed in a timely fashion.
~ Peter Lurie (January 16, 1962 - )