Glossary of Acronyms and Abbreviations

ADUFA:  Animal Drug User Fee Act

AGDUFA:  Animal Generic Drug User Fee Act

ANDA:  Abbreviated New Drug Application

ANPRM:  Advanced Notice of Proposed Rulemaking

BLA:  Biologics Licensing Application

CBER:  Center for Biologics Evaluation and Research

CBP:  United States Customs and Border Protection

CDER:  Center for Drug Evaluation and Research

CDRH:  Center for Devices and Radiological Health

CFSAN:  Center for Food Safety and Applied Nutrition

CMS:  Centers for Medicare and Medicaid Services

CVM:  Center for Veterinary Medicine

DDI:  Division of Drug Information

DIOP:  Division of Import Operations and Policy

DSMICA:  Division of Small Manufacturers, International and Consumer Assistance

DWPE:  Detained Without Physical Examination

FDA:  United States Food and Drug Administration

FD&C Act: Federal Food, Drug and Cosmetic Act

FTC:  Federal Trade Commission

HHS:  United States Department of Health and Human Services

ITACS:  Import Trade Auxiliary Communications System

MDUFMA:  Medical Device User Fee and Modernization Act
 

NDA:  New Drug Application

NCIE:  Notices of Claimed Investigational Exemption for a New Animal Drug

NPRM:  Notice of Proposed Rulemaking

OASIS:  Operational and Administrative System for Import Support

OC:  Office of the Commissioner

OGD:  Office of Generic Drugs

OIG:  Office of the Inspector General

OMB:  Office of Management and Budget

OND:  Office of New Drugs

ORA:  Office of Regulatory Affairs

PDUFA:  Prescription Drug User Fee Act

PMA:  Premarket Approval

REMS:  Risk Evaluation and Mitigation Strategies

RPM:  Regulatory Project Manager