Trends in boxed warnings and withdrawals for novel therapeutic drugs, 1996 through 2012

JAMA Intern Med. 2014 Oct;174(10):1704-5. doi: 10.1001/jamainternmed.2014.4854.

Authors

Christine M Cheng¹, Jaekyu Shin², B Joseph Guglielmo²

Affiliations

¹ Disease Decision Support Group, First Databank Inc, San Francisco, California2Department of Clinical Pharmacy, San Francisco School of Pharmacy, University of California, San Francisco.
² Department of Clinical Pharmacy, San Francisco School of Pharmacy, University of California, San Francisco.

PMID: 25127107
DOI: 10.1001/jamainternmed.2014.4854

No abstract available

MeSH terms

Drug Approval*
Drug Industry / legislation & jurisprudence
Drug Labeling / standards*
Drug Labeling / trends*
Drug-Related Side Effects and Adverse Reactions*
Humans
Legislation, Drug
Logistic Models
Marketing
Product Surveillance, Postmarketing
United States
United States Food and Drug Administration