Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments
Author(s) -
Joshua J. Skydel,
Anita T. Luxkaranayagam,
Sanket S. Dhruva,
Joseph S. Ross,
Joshua D. Wallach
Publication year - 2019
Publication title -
jama network open
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.278
H-Index - 39
ISSN - 2574-3805
DOI - 10.1001/jamanetworkopen.2019.3410
Subject(s) - medicine , postmarketing surveillance , clinical trial , food and drug administration , clinical research , pharmacology , adverse effect
This cross-sectional study characterizes postapproval clinical trials sponsored by pharmaceutical companies of therapeutics approved by the US Food and Drug Administration (FDA) without postmarketing requirements or commitments.
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