Moving goalposts--regulatory oversight of antibacterial drugs

Randall Brenner; Evelyn J Ellis-Grosse; Roger Echols

doi:10.1038/nbt1206-1515

Moving goalposts--regulatory oversight of antibacterial drugs

Nat Biotechnol. 2006 Dec;24(12):1515-20. doi: 10.1038/nbt1206-1515.

Authors

Randall Brenner¹, Evelyn J Ellis-Grosse, Roger Echols

Affiliation

¹ Wyeth Pharmaceuticals, 500 Arcolo Road, Collegeville, Pennsylvania 19426, USA. brenner1@wyeth.com

PMID: 17160053
DOI: 10.1038/nbt1206-1515

Abstract

Is uncertainty concerning the regulation of antimicrobial drug trials stifling investment in infectious disease treatments? Here, experts from a large pharma company and a biotech firm provide their perspectives.

MeSH terms

Anti-Bacterial Agents* / biosynthesis
Anti-Bacterial Agents* / chemical synthesis
Biotechnology / legislation & jurisprudence*
Clinical Trials as Topic / standards*
Drug Approval / legislation & jurisprudence*
Drug Industry / legislation & jurisprudence*
Microbial Sensitivity Tests / methods
United States

Substances

Anti-Bacterial Agents