Accelerated approval of oncology drugs: Can we do better?

Journal of the National Cancer Institute

Volumn 103, Issue 8, 2011, Pages 616-617

  Ellenberg, Susan S ^a  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; GEFITINIB; IMATINIB;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; BREAST CANCER; CANCER SURVIVAL; CANCER THERAPY; DRUG APPROVAL; EDITORIAL; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL TUMOR; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MULTIPLE SCLEROSIS; PRIORITY JOURNAL; TREATMENT INDICATION;

ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; DRUG INDUSTRY; HUMANS; LEGISLATION, DRUG; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TIME FACTORS; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 79955388599     PISSN: 00278874     EISSN: 14602105     Source Type: Journal    
DOI: 10.1093/jnci/djr104     Document Type: Editorial

References (10)

1. "Applications for FDA Approval to Market a New Drug." Code of Federal Regulations Title 21 Part 314. Washington, DC: U.S. Government Printing Office; 2010 ed.
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9. Government Accountability Office. (September 23, 2009). New Drug Approval: FDA Needs to Enhance its Oversight of Drugs Approved on the Basis of Surrogate Endpoints. (Publication No. GAO-09-866). Government Printing Office, 2009. Retrieved from http://www.gao.gov/new.items/d09866.pdf. Accessed March 15, 2011.
10. FDA Office of the Commissioner, Office of Chief Scientist. (October 2010). Advancing Regulatory Science for Public Health. U.S. Food and Drug Administration. Accessed at http://www.fda.gov/ScienceResearch/SpecialTopics/ RegulatoryScience/ucm228131.htm. Accessed March 15, 2011.