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U.S. Department of Health and Human Services

About FDA

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Abbreviations Used in This Report

Table of Contents: A Review of FDA’s Approach to Medical Product Shortages

AHA:

American Hospital Association

ANDA:

Abbreviated New Drug Application

API:

Active Pharmaceutical Ingredient

ASA:

American Society of Anesthesiologists

ASCO:

American Society of Clinical Oncology

ASHP:

American Society of Health-System Pharmacists

ASPE:

Assistant Secretary for Planning and Evaluation

BLA:

Biologics License Application

CBER:

Center for Biologics Evaluation and Research

CDER:

Center for Drug Evaluation and Research

CDRH:

Center for Devices and Radiological Health

CVM:

Center for Veterinary Medicine

DHHS:

Department of Health and Human Services

DSP:

Drug Shortage Program

FDA:

Food and Drug Administration

FD&C Act:

Food, Drug, and Cosmetic Act

GAO:

Government Accountability Office

GMP:

Good Manufacturing Practice

GPO:

Group Purchasing Organization

ISMP:

Institute for Safe Medical Practices

MAPP:

Manual of Policies and Procedures

NDA:

New Drug Application

OAI:

Official Action Indicated

OCBQ:

Office of Compliance and Biologics Quality, CBER

OMPQ:

Office of Manufacturing and Product Quality, CDER

ORA:

Office of Regulatory Affairs

OSC:

Office of Surveillance and Compliance, CVM

OSE:

Office of Surveillance and Epidemiology, CDER

OTC:

over-the-counter

SOP (SOPP):

Standard Operating Procedures (and Policies)

UDI:

Unapproved Drugs Initiative

 Next section: Introduction and Background