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Suggested Citation:"Acronyms and Abbreviations." Institute of Medicine and National Research Council. 2005. Federal Agency Roles in Cancer Drug Development from Preclinical Research to New Drug Approval: The National Cancer Institute and the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/11257.
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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

Suggested Citation:"Acronyms and Abbreviations." Institute of Medicine and National Research Council. 2005. Federal Agency Roles in Cancer Drug Development from Preclinical Research to New Drug Approval: The National Cancer Institute and the Food and Drug Administration. Washington, DC: The National Academies Press. doi: 10.17226/11257.
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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 Get This Book
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Federal Agency Roles in Cancer Drug Development from Preclinical Research to New Drug Approval is an authored background paper describing the federal role in cancer drug development. This report is a part of a project of the National Cancer Policy Board to analyze every aspect of the way new agents to fight cancer are developed and to search for ways to streamline the process. This paper provides useful background detail for those interested in exploring issues that will be informed by how the FDA and NCI act and interact to develop cancer drugs from preclinical research to new drug approval.

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