Timing of New Black Box Warnings and Withdrawals for Prescription Medications

20021,007 citationsJournal Article

Authors

Abstract

Serious ADRs commonly emerge after Food and Drug Administration approval. The safety of new agents cannot be known with certainty until a drug has been on the market for many years.

Topics & Keywords

Pharmaceutical industry and healthcare Pharmaceutical studies and practices Pharmacovigilance and Adverse Drug Reactions

UN Sustainable Development Goals

Good health and well-being

Publication Details

Published in: JAMA

Volume 287, Issue 17, pp. 2215-2215

DOI: 10.1001/jama.287.17.2215

Field-Weighted Citation Impact: 46.97