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OCR for page 61
Federal Agency Roles in Cancer Drug Development from Preclinical Research to New Drug Approval: The National Cancer Institute and the Food and Drug Administration 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
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