New FDA regulation to improve safety reporting in clinical trials.

The New England journal of medicine ·Vol. 365 ·No. 1 ·2011-07-07 ·Pages 3-5

Sherman RB, Woodcock J, Norden J, Grandinetti C, Temple RJ

Abstract

暂无摘要

MeSH Terms

Adverse Drug Reaction Reporting Systems/legislation & jurisprudence Clinical Trials as Topic/legislation & jurisprudence Drug-Related Side Effects and Adverse Reactions Government Regulation Humans United States United States Food and Drug Administration

Authors & Affiliations

5 authors, click to expand affiliations / ORCID

Sherman Rachel Behrman

Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.

Woodcock Janet

Norden Janet

Grandinetti Cheryl

Temple Robert J

Article Info

Journal

The New England journal of medicine

Abbr.

N Engl J Med

ISSN

1533-4406

DOI

10.1056/NEJMp1103464

Published

2011-07-07

Epub

2011-00-08

Pages

3-5

Language

English

Region

United States

NLM ID

0255562

Subset

External Links

PubMed source DOI: 10.1056/NEJMp1103464 View journal details

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New FDA regulation to improve safety reporting in clinical trials.

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