Journal ArticleOPEN ACCESS

Practical, Legal, and Ethical Issues in Expanded Access to Investigational Drugs

  • Darrow J
  • Sarpatwari A
  • Avorn J
  • et al.
New England Journal of Medicine (2015) 372(3) 279-286
DOI: 10.1056/nejmhle1409465
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Abstract

The authors review the FDA policies and procedures that permit some patients with serious conditions to receive investigational drugs before formal product approval and examine the legal and ethical issues associated with expanded access.

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APA

Darrow, J. J., Sarpatwari, A., Avorn, J., & Kesselheim, A. S. (2015). Practical, Legal, and Ethical Issues in Expanded Access to Investigational Drugs. New England Journal of Medicine, 372(3), 279–286. https://doi.org/10.1056/nejmhle1409465

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