Expediting the availability of drugs for US patients with cancer

Nature Clinical Practice Urology

Volumn 5, Issue 12, 2008, Pages 654-656

  Farrell, Ann T ^a   Pazdur, Richard ^b   von Eschenbach, Andrew C ^c  

^a Division of Oncology Drug Products   (United States)

^b Department of Oncology Drug Products ^*  (United States)

^c CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ASPARAGINASE; AZACITIDINE; CISPLATIN; DOCETAXEL; FLUDARABINE; GEFITINIB; GEMCITABINE; OXALIPLATIN; PACLITAXEL; PEMETREXED; TEMOZOLOMIDE; TRASTUZUMAB;

ARTICLE; BREAST CANCER; CANCER CHEMOTHERAPY; CHRONIC MYELOID LEUKEMIA; CLINICAL TRIAL; COLORECTAL CANCER; DRUG APPROVAL; DRUG EFFICACY; DRUG INDUSTRY; DRUG MARKETING; DRUG RESEARCH; DRUG RESPONSE; DRUG SAFETY; GLIOMA; HEALTH CARE ACCESS; HUMAN; LUNG NON SMALL CELL CANCER; MESOTHELIOMA; PANCREAS CANCER; PHARMACEUTICAL CARE; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; UNITED STATES;

ANTINEOPLASTIC AGENTS; DRUG APPROVAL; HUMANS; NEOPLASMS; UNITED STATES;

EID: 57449094780     PISSN: 17434270     EISSN: 17434289     Source Type: Journal    
DOI: 10.1038/ncpuro1255     Document Type: Article

References (17)

1. US Food and Drug Administration (online 31 December 2005) Code of Federal Regulations- Title 21: Food and Drugs 314.126 - Adequate and well-controlled studies [http://vlex.com/vid/19710185] (accessed 11 October 2008)
2. Temple R (1996) Development of drug law, regulations, and guidance in the United States. In Principles of Pharmacology: Basic Concepts and Clinical Applications, 1643-1665 (Eds Munson PL et al.) New York: Chapman & Hall
3. Johnson JR and Temple R (1985) Food and Drug Administration requirements for approval of new anticancer drugs. Cancer Treat Rep 69: 1155-1159
4. US Food and Drug Administration (online 11 December 1992) Code of Federal Regulations - Title 21: Food and Drugs 314 and 601 - New Drug, Antibiotic, and Biologic Product Regulations; Accelerated Approval 57 FR 58942 [http://www. fda.gov/cder/fedreg/fr19921211.txt] (accessed 11 October 2008)
5. Johnson JR et al. (2003) End points and United States Food and Drug Administration approval of oncology drugs. J Clin Oncol 21 1404-1411
6. US Food and Drug Administration (online 31 December 2005) Code of Federal Regulations- Title 21: Food and Drugs 314.530 - Withdrawal procedures [http://vlex.com/vid/19708988] (accessed 11 October 2008)
7. Dagher R et al. (2004) Accelerated approval of oncology products: a decade of experience. J Natl Cancer Inst 96: 1500-1509
8. US Food and Drug Administration (online 31 May 2007) Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics [http://www.fda.gov/cder/guidance/7478fnl.pdf] (accessed 11 October 2008)
9. US Food and Drug Administration (online 31 May 1998) Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products [http://www.fda.gov/cder/guidance/1397fnl.pdf] (accessed 11 October 2008)
10. US Food and Drug Administration (online 31 May 2001) E 10 Choice of Control Group and Related Issues in Clinical Trials [http://www.fda.gov/ cder/guidance/4155fnl.pdf] (accessed 11 October 2008)
11. US Food and Drug Administration (online 31 December 2005) Code of Federal Regulations- Title 21: Food and Drugs 312.34 - Treatment use of an investigational new drug [http://vlex.com/vid/19709947] (accessed 11 October 2008)
12. Farrell A et al. (2008) FDA's role in the development and approval of drugs, biologics, and devices for cancer. In DeVita, Hellman, and Rosenberg's Cancer: Principles & Practice of Oncology, edn 8 2914-2925 (Eds DeVita VT et al.) Philadelphia: Lippincott Williams & Wilkins
13. US Food and Drug Administration (online 31 March 2002) Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions [http://www.fda.gov/cder/ guidance/4856fnl.pdf] (accessed 11 October 2008)
14. US Food and Drug Administration (online 14 December 2006) Code of Federal Regulations- Title 21: Food and Drugs 312 - Expanded Access to Investigational Drugs for Treatment Use [http://www. fda.gov/OHRMS/ DOCKETS/98fr/06-9684.pdf] (accessed 11 October 2008)
15. US Food and Drug Administration (online 31 July 2004) Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review [http://www.fda.gov/cder/guidance/ 5645fnl.pdf] (accessed 11 October 2008)
16. US Food and Drug Administration (online 31 December 1998) Guidance for Industry: FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products [http://www. fda.gov/cder/guidance/1484fnl.pdf] (accessed 11 October 2008)
17. US Food and Drug Administration (online 31 October 2001) Guidance for Industry: Cancer Drug and Biological Products - Clinical Data in Marketing Applications [http://www.fda.gov/cder/guidance/4332fnl.pdf] (accessed 11 October 2008)