Accelerated Approval and Other Regulatory Approaches to Drug Development for Serious Diseases in Pediatrics

Pediatric Drug Development: Concepts and Applications

Volumn , Issue , 2013, Pages 123-129

  Cvetkovich, Therese ^a  

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

Author keywords

Drug development; Food and drug administration (FDA) programs; HIV infection; Pediatric diseases

Indexed keywords

EID: 84902351832     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9781118312087.ch12     Document Type: Chapter

References (7)

1. Johnson JR, Ning Y-M, Farrell A. et al. Accelerated approval of oncology products: The Food and Drug Administration experience. J Natl Cancer Inst 2011; 103: 636-644.
2. Miyamoto BE, Kakkis ED. The potential investment impact of improved access to accelerated approval on the development of treatments for low prevalence rare diseases. Orphanet Journal of Rare Diseases 20116: 49.
3. http: //www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM230597.pdf
4. http: //www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072008.pdf
5. http: //www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM077104.pdf
6. Chabner BA. Early accelerated approval for highly targeted cancer drugs. N Engl J Med 2011; 364; 12: 1087-1089.
7. Mani N, Murray J, Gulick R.M. et al. Novel clinical trial designs for the development of new antiretroviral agents. AIDS 2012; 26: 899-907.