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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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