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Accelerated Approval — Taking the FDA’s Concerns Seriously

List of authors.
  • Rachel E. Sachs, J.D., M.P.H.,
  • Julie M. Donohue, Ph.D.,
  • and Stacie B. Dusetzina, Ph.D.

User-fee reauthorization creates new opportunities for the FDA to address issues with its accelerated-approval program, including the lack of evidence of clinical benefit for some products.

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Funding and Disclosures

Disclosure forms provided by the authors are available at NEJM.org.

This article was published on July 6, 2022, at NEJM.org.

Author Affiliations

From Washington University in St. Louis School of Law, St. Louis (R.E.S.); the Department of Health Policy and Management, University of Pittsburgh Graduate School of Public Health, Pittsburgh (J.M.D.); and the Department of Health Policy, Vanderbilt University School of Medicine, and the Vanderbilt–Ingram Cancer Center — both in Nashville (S.B.D.).

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