Citation

Benet LZ. Clin. Pharmacol. Ther. 2007; 81(2): 158-161.

Affiliation

Department of Biopharmaceutical Sciences, University of California San Francisco, San Francisco, California, USA. Leslie.Benet@ucsf.edu

Copyright

(Copyright © 2007, American Society for Clinical Pharmacology and Therapeutics, Publisher Nature Publishing Group)

DOI

10.1038/sj.clpt.6100083

PMID

17259941

Abstract

In September 2006 an Institute of Medicine (IOM) ad hoc committee on the Assessment of the US Drug Safety System released its report entitled "The Future of Drug Safety: Promoting and Protecting the Health of the Public". The committee's report includes 25 recommendations that "will bring the strengths of the preapproval process (data, regulatory authority, organizational function and capabilities, and resources) to the postapproval phase in order to fulfill a lifecycle approach to the study, regulation, and communication about the risks and benefits of drugs." Copies of the report are available from the National Academies Press (800-624-6242), and the full text is available at http://www.nap.edu.

Language: en