Drug-review deadlines and safety problems.

  title={Drug-review deadlines and safety problems.},
  author={C. Nardinelli and Michael L Lanthier and R. Temple},
  journal={The New England journal of medicine},
  volume={359 1},
          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… Expand
Drug-review deadlines and safety problems.
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