Accelerated approval of cancer drugs: Improved access to therapeutic breakthroughs or early release of unsafe and ineffective drugs? Academic Article uri icon

Overview

MeSH Major

  • Drug Approval
  • Orphan Drug Production
  • United States Food and Drug Administration

abstract

  • AA oncology NMEs are safe and effective, although development times are not accelerated. A return to endorsing phase II trial designs for AA for oncology NMEs, particularly for orphan drug indications, may facilitate timely FDA approval of novel cancer drugs.

publication date

  • September 10, 2009

Research

keywords

  • Academic Article

Identity

Language

  • eng

PubMed Central ID

  • PMC2744277

Digital Object Identifier (DOI)

  • 10.1200/JCO.2008.21.1961

PubMed ID

  • 19636013

Additional Document Info

start page

  • 4398

end page

  • 405

volume

  • 27

number

  • 26