Definitions Which Apply To The Drug Industry

356V

Form for New Animal Drug Application (NADA)

AADA 

Abbreviated Antibiotic Drug Application 

Acceptance Criteria 

The product specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level, with an associated sampling plan, that are necessary for making a decision to accept or reject a lot or batch (or any other convenient subgroups of manufactured units). [From §210.3(b)(20)] 

Active Ingredient 

Any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. [Adapted from §210.3(b)(7)] 

Actual Yield  

The quantity that is actually produced at any appropriate phase of manufacture, processing, or packing of a particular drug product. [From §210.3(b)(18)] 

ADE 

Adverse Drug Event 

ADR 

Adverse Drug Reaction 

AIM 

Active Ingredient Manufacturer 

AIP

Application Integrity Policy

ANADA 

Abbreviated New Drug Application 

ANDA 

Abbreviated New Drug Application 

Batch 

A specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture. [From §210.3(b)(2)] 

Batch Number 

See Lot Number 

BIMO

Bioresearch Monitoring

BIND 

Biological Investigational New Drug 

CAC

Carcinogenicity Assessment Committee

CANDA 

Computer Assisted New Drug Application 

CAPD

Continuous Ambulatory Peritoneal Dialysis

CAPLA 

Computer Assisted Product License Application 

CBER

Center for Biologics Evaluation and Research

CDC

Center for Disease Control and Prevention

CDER

Center for Drug Evaluation and Research

CESS

CDER Executive Secretariat Staff

CFC

Chloro Flouro Carbon

CGMP

Current Good Manufacturing Practices

CMC

Chemistry, Manufacturing, and Controls

CNS

Central Nervous System

Component 

Any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such drug product. [From §210.3(b)(3)] 

Control Number 

See Lot Number 

CSA

Controlled Substances Act

CSET

Controlled Substance Evaluation Team

CSO

Consumer Safety Officer

CVM

Center for Veterinary Medicine

DADS

Developers and Distributors System

DCM

Division of Communications Management

DEA

Drug Enforcement Administration

DESI

Drug Efficacy Study Implementation

DMF 

Drug Master File 

DMSO

Dimethylsulfoxide

DNA

Deoxyribonucleic Acid

DPRF

Drug Product Reference File

DQRS

Drug Quality Reporting System

DRLS

Drug Registration and Listing System

Drug Product 

A finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo. [From §210.3(b)(4)] 

FDA

Food and Drug Administration

Fiber 

Any particulate contaminant with a length at least three times greater than its width. [From §210.3(b)(5)] 

FOI

Freedom of Information

Gang-Printed Labeling 

Labeling derived from a sheet of material on which more than one item of labeling is printed. [From §210.3(b)(22)] 

GAO

Government Accounting Office

GCP

Good Clinical Practice

GI

Gastrointestinal

GLP

Good Laboratory Practice

GMP

Good Manufacturing Practice

HFD

FDA Internal Mail Code - Drugs

ICDC

Interagency Committee on Drug Control

IG

Inspector General

Inactive Ingredient 

Any component other than an "active ingredient." [From §210.3(b)(8)] 

IND

Investigational New Drug Application

In-Process Material 

Any material fabricated, compounded, blended or derived by chemical reaction that is produced for, and used in, the preparation of the drug product. [From §210.3(b)(9)] 

IRB

Institutional Review Board

Lot 

A batch, or a specific identified portion of a batch, having uniform character and quality within specified limits; or in the case of a drug product produced by continuous process, it is a specific identified amount produced in a unit of time or quantity in a manner that assures its having uniform character and quality within specified limits. [From §210.3(b)(10)] 

Lot Number, Control Number, or Batch Number 

Any distinctive combination of letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacture, processing, packing, holding, and distribution of a batch or lot of drug product or other material can be determined. [From §210.3(b)(11)]  

LTE

Less Than Effective

Manufacture, Processing, Packing or Holding of a Drug Product  

Includes packaging and labeling operations, testing, and quality control of drug products. [From §210.3(b)(12)] 

NADA 

New Animal Drug Application 

NCTR

National Center for Toxicological Research

NDA 

New Drug Application 

NDE

New Drug Entity

NIDA

National Institute on Drug Abuse

Non-Fiber Releasing Filter 

Any filter, which after any appropriate pretreatment such as washing or flushing, will not release fibers into the component or drug product that is being filtered. All filters composed of asbestos are deemed to be fiber-releasing filters. [From §210.3(b)(6)] 

OC

Office of Compliance

OCPB

Office of Clinical Pharmacology and Biopharmaceutics

ODE

Office of Drug Evaluation

OEB

Office of Epidemiology and Biostatistics

OGD

Office of Generic Drugs

OHA

Office of Health Affairs

OIT

Office of Information Technology

OM

Office of Management

ONDC

Office of New Drug Chemistry

OPS

Office of Pharmaceutical Science

ORM

Office of Review Management

OTC 

Over The Counter Drugs 

OTCOM

Office of Training and Communications

OTR

Office of Testing and Research

Percentage of Theoretical Yield 

The ratio of the actual yield (at any appropriate phase of manufacture, processing, or packing of a particular drug product) to the theoretical yield (at the same phase), stated as a percentage. [From §210.3(b)(19)] 

PET 

Positron Emission Tomography 

POST MS

Postmarketing Surveillance

PPI 

Patient Package Insert 

Representative Sample 

A sample that consists of a number of units that are drawn based on rational criteria such as random sampling and intended to assure that the sample accurately portrays the material being sampled. [From §210.3(b)(21)] 

Strength 

(i) The concentration of the drug substance (for example weight/weight, weight/volume, or unit dose/volume basis) and/or (ii) The potency, that is the therapeutic activity of the drug product as indicated by appropriate laboratory tests or by adequately developed and controlled clinical data (expressed, for example, in terms of units by reference to a standard.) [From §210.3(b)(16)] 

Theoretical Yield 

The quantity that would be produced at any appropriate phase of manufacture, processing, or packing of a particular drug product, based upon the quantity of components to be used, in the absence of any loss or error in actual production. [From §210.3(b)(17)]