Drug Manufacturers' Delayed Disclosure of Serious and Unexpected Adverse Events to the US Food and Drug Administration

JAMA Intern Med. 2015 Sep;175(9):1565-6. doi: 10.1001/jamainternmed.2015.3565.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adverse Drug Reaction Reporting Systems / statistics & numerical data*
  • Disclosure / statistics & numerical data*
  • Drug-Related Side Effects and Adverse Reactions*
  • Humans
  • Time Factors
  • United States
  • United States Food and Drug Administration