FDA Abbreviations

In an exuberant effort at being concise and efficient, various organizations (with the government at the top of the list) have created individualized pseudo languages.

This has created and established recognizable, abbreviated language that can be both intimidating and frustrating for those of us required to use and understand it and those not.

The confusing aspect is that there is no central Organization for the Establishment of Abbreviations and Acronyms or, as it might be transposed in this context, the non-existent OEAA (a lame attempt at getting a point across).

Abbreviations and acronyms do not necessarily cross organizational or company lines. The meaning of an abbreviation for one organization does not necessarily mean it will apply within other companies or organizations.

In the FDA (Food and Drug Administration) the acronym ADR stands for Adverse Drug Reaction. In the EPA (Environmental Protection Agency) that same acronym stands for Alternate Dispute Resolution. In the EPA, RF stands for Response Factor. In ASME (American Society for Mechanical Engineers) that same abbreviation stands for Raised Face (flange).

What we are attempting to do here is provide you with a listing of the various abbreviations and acronyms, along with their parent terminology, as they apply in their originating organization, if they have one.

Quite a large number of these abbreviations and acronyms have more or less evolved into the industry. Each company, whether it's an engineering firm or a manufacturer, has a tendency to extend and modify industry-excepted abbreviations and create its own library of abbreviations, acronyms and terminology definition. More so for the manufacturer whose incentive is in the hope of maintaining continuity and understanding from project to project.

An industrial facility, throughout its existence, will undergo continuous change through capitol and maintenance projects. These expansions and modifications will be done by an assortment of design and construction firms leaving in their wake project files that contain an assortment of design formats. That is, unless the owner is in a position to provide their own design criteria.

It is with the hope of creating some continuity, with regard to the use of abbreviations and acronyms throughout the industry, that we are providing these lists. Some will be
specific to a particular organization and some will be general to the industry.

Abbreviations & Acronyms, FDA

510(k): Medical Device Premarket Notification

AADA: Abbreviated Antibiotic Drug Application
ADR: Adverse Drug Reaction
AFDO: Association of Food and Drug Officials
ANADA: Abbreviated New Animal Drug Application
ANDA: Abbreviated New Drug Application
AOAC: Association of Official Analytical Chemists
APHIS: Animal and Plant Health Inspection Service
ATF: Alcohol, Tobacco, and Firearms (Bureau of)

CANDA: Computer Assisted New Drug Application
CBER: Center for Biologics Evaluation and Research
CDC: Centers for Disease Control and Prevention
CDER: Center for Drug Evaluation and Research
CDRH: Center for Devices and Radiological Health
CFR: Code of Federal Regulations
CFSAN: Center for Food Safety and Applied Nutrition
CSI: Consumer Safety Inspector
CSO: Consumer Safety Officer
CVM: Center for Veterinary Medicine

DAL: Defect Action Level
DD: District Director
DEA: Drug Enforcement Administration
DESI: Drug Efficacy Study Implementation
DHHS: Department of Health and Human Services

EPA: Environmental Protection Agency

FDC: Food, Drug, & Cosmetic
FOIA: Freedom of Information Act
FR: Federal Register
FSIS: Food Safety and Inspection Service
FTE: Full Time Equivalent (employee)
FTC: Federal Trade Commission
FY: Fiscal Year

GATT: General Agreement on Tariffs and Trade
GLP: Good Laboratory Practice
(c)GMP: (current)Good Manufacturing Practice
GRAS: Generally Recognized as Safe (food ingredients)

HACCP: Hazard Analysis Critical Control Point (inspection technique)

IDE: Investigational Device Exemption
INADA: Investigational New Animal Drug Application
IND: Investigational New Drug (application)
IRB: Institutional Review Board

LACF: Low Acid Canned Food

MOD 1: Module One (laboratory facility)
MOD 2: Module Two (laboratory facility)
MOU: Memorandum of Understanding
MQSA: Mammography Quality Standards Act of 1992

NADA: New Animal Drug Application
NAFTA: North American Free Trade Agreement
NCE: New Chemical Entity
NCI: National Cancer Institute
NCTR: National Center for Toxicological Research
NDA: New Drug Application
NIH: National Institutes of Health
NLEA: Nutrition Labeling and Education Act of 1990
NME: New Molecular Entity
NMFS: National Marine Fisheries Service

OC: Office of the Commissioner
OCA: Office of Consumer Affairs
OCI: Office of Criminal Investigation
OEI: Official Establishment Inventory
OHA: Office of Health Affairs
OLA: Office of Legislative Affairs
OPA: Office of Public Affairs
OPE: Office of Planning and Evaluation
ORA: Office of Regulatory Affairs
OTC: Over-the-Counter (drugs)

PAS: Public Affairs Specialist
PDMA: Prescription Drug Marketing Act
PDP: Product Development Protocols (for medical devices)
PHS: Public Health Service
PLA: Product License Application (for biologics)
PMA: Pre-Market Approval (application) (for medical devices)

RFDD: Regional Food and Drug Director

SBA: Summary Basis of Approval
SMDA: Safe Medical Devices Act

USC: United States Code
USDA: United States Department of Agriculture
USP: United States Pharmacopeia

VAERS: Vaccine Adverse Event Reporting System

WEAC: Winchester Engineering and Analytical Center