New FDA regulation to improve safety reporting in clinical trials

N Engl J Med. 2011 Jul 7;365(1):3-5. doi: 10.1056/NEJMp1103464. Epub 2011 Jun 8.

Authors

Rachel Behrman Sherman¹, Janet Woodcock, Janet Norden, Cheryl Grandinetti, Robert J Temple

Affiliation

¹ Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.

PMID: 21651388
DOI: 10.1056/NEJMp1103464

No abstract available

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