Drug-review deadlines and safety problems.

@article{Nardinelli2008DrugreviewDA,
  title={Drug-review deadlines and safety problems.},
  author={Clark Nardinelli and Michael L Lanthier and Robert J. Temple},
  journal={The New England journal of medicine},
  year={2008},
  volume={359 1},
  pages={
          95-6; author reply 96-8
        }
}
n engl j med 359;1 www.nejm.org july 3, 2008 95 To the Editor: Carpenter et al. (March 27 is­ sue)1 report that new molecular entities (NMEs) approved in the 2 months before the first review deadlines established under the Prescription Drug User Fee Act (PDUFA) showed a higher rate of postmarketing safety problems — as measured by safety­based withdrawals, new black­box warn­ ings, or dosage­form discontinuations — than drugs approved at any other time. They suggest that pressure to respond… 

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Drug-review deadlines and safety problems.
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PDUFA deadlines have appreciably changed the approval decisions of the FDA, and once medications are in clinical use, the discovery of safety problems is more likely for drugs approved immediately before a deadline than for those approved at other times.
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