API
Active Pharmaceutical Ingredient

ADR
Adverse Drug Reaction

AE
Adverse Event

ANDA
Abbreviated New Drug Application

CFR
Code of Federal Regulations

CRO
Contract Research Organization

CT
Clinical Trial

DHA
Drug Half-Life

DMR
Drug Master File

DUR
Drug Utilization Review

ED50
Effective Dose 50

GMP
Good Manufacturing Practice

IND
Investigational New Drug

IRB
Institutional Review Board

NDA
New Drug Application

OTC
Over-The-Counter

PA
Pharmacologic Activity

PK
Pharmacokinetics

PD
Pharmacodynamics

PDUFA
Prescription Drug User Fee Act

PI
Product Information

PMDA
Pharmaceuticals and Medical Devices Agency

PR
Product Recall

RCT
Randomized Controlled Trial

Rx
Prescription

SOP
Standard Operating Procedure

USP
United States Pharmacopeia