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Health Care Policy and Law
March 2, 2020

Integrated Drug Reviews at the US Food and Drug Administration—Legal Concerns and Knowledge Lost

Author Affiliations
  • 1Health Law Institute, Schulich School of Law, Dalhousie University, Halifax, Nova Scotia, Canada
  • 2Department of Pharmacology, Faculty of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada
  • 3Engelberg Center on Innovation Law & Policy, New York University School of Law, New York
  • 4Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore
JAMA Intern Med. 2020;180(5):629-630. doi:10.1001/jamainternmed.2020.0074

When the US Food and Drug Administration (FDA) approves a new drug, federal law requires public disclosure of the review documents prepared by scientific disciplines (eg, clinical, toxicology, statistical) during the review.1 These scientific reviews are published on the FDA Drugs@FDA website (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm). In many cases, the data and analyses contained in those reviews have proved useful to public health.

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