The Fate of FDA Postapproval Studies

N Engl J Med. 2017 Sep 21;377(12):1114-1117. doi: 10.1056/NEJMp1705800.

Authors

Steven Woloshin¹, Lisa M Schwartz¹, Brian White¹, Thomas J Moore¹

Affiliation

¹ From the Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, NH (S.W., L.M.S.); AtlantiCare Regional Medical Center, Pomona, NJ (B.W.) ; the Institute for Safe Medication Practices, Alexandria, VA (T.J.M.); and the Department of Epidemiology and Biostatistics, George Washington University Milken Institute School of Public Health, Washington, DC (T.J.M.).

PMID: 28930510
DOI: 10.1056/NEJMp1705800

No abstract available

MeSH terms

Clinical Trials, Phase IV as Topic*
Databases, Factual
Drug Approval*
Humans
Product Surveillance, Postmarketing*
United States
United States Food and Drug Administration*