Federal Agency Roles in Cancer Drug Development from Preclinical Research to New Drug Approval: The National Cancer Institute and the Food and Drug Administration (2005)
Chapter: Acronyms and Abbreviations
ACRONYMS AND ABBREVIATIONS
BDP
Biopharmaceutical Development Program
BLA
Biologics License Application
BRM
Biological Response Modifier
CBER
Center for Biologics Evaluation and Research
CCNSC
Cancer Chemotherapy National Service Center
CDER
Center for Drug Evaluation and Research
CDRH
Center for Devices and Radiological Health
CFR
U.S. Code of Federal Regulations
CFSAN
Center for Food Safety and Applied Nutrition
CGAP
Cancer Genome Anatomy Project
CMS
Centers for Medicare and Medicaid Services
DCTD
Division of Cancer Treatment and Diagnosis
DNA
Deoxyribonucleic acid
DTP
Developmental Therapeutics Program
EDRN
Early Detection Research Network
ELA
Establishment Licensing Application
FDA
Food and Drug Administration
FDAMA
Food and Drug Administration Modernization Act of 1997
FDCA
Food, Drug, and Cosmetic Act of 1938
FLAIR
Flexible System to Advance Innovative Research
IND
Investigational New Drug Exemption
IRB
Institutional Review Board
LMT
Laboratory of Molecular Technology
NCAB
National Cancer Advisory Board
NCCN
National Comprehensive Cancer Network
NCDDG
National Cooperative Drug Discovery Group Program
NDA
New Drug Application
NIH
National Institutes of Health
NME
New Molecular Entity
ODAC
Oncologic Drugs Advisory Board
ODP
Office of Oncology Drug Products
OTC
Over-the-Counter (non-prescription) drug
PDUFA
Prescription Drug User Fee Act of 1992
PhRMA
Pharmaceutical Research and Manufacturers of America
PLA
Product License Application
RAID
Rapid Access to Intervention Development Program
RAMEM
Radiation Modifier Evaluation Module Program
RAND
Rapid Access to NCI Discovery Resources Program
RFA
Request for Applications
RNA
Ribonucleic Acid
SAGE
Serial Analysis of Gene Expression
SPORE
Specialized Program of Research Excellence
TIP
Time to progression
