ADME: Absorption, Distribution, Metabolism, Excretion
ANDA: Abbreviated New Drug Application
API: Active Pharmaceutical Ingredient
ATMPs: Advanced Therapy Medicinal Products
BLA: Biologic License Application
BsUFA: Biosimilar User Fee Act
CAT: Committee for Advanced Therapies
CBER: Center for Biologics Evaluation and Research
CDER: Center for Drug Evaluation and Research
CFR: Code of Federal Regulations
CHMP: Committee for Medicinal Products for Human Use
CHO: Chinese Hamster Ovary (cell)
CMC: Chemistry, Manufacturing and Controls
CMO: Contract Manufacturing Organization
CMS: Centers for Medicare and Medicaid Services
COMP: Committee for Orphan Medicinal Products
CRA: Clinical Research Associate
CRO: Clinical Research Organization, Contract Research Organization
CTA: Clinical Trial Application
DDMAC: Division of Drug Marketing, Advertising and Communications
DHHS: Department of Health & Human Services
DMC: Data Monitoring Committee
DMPK: Drug Metabolism and Pharmacokinetic (Studies)
DSMB: Data Safety Monitoring Committee
EMA: European Medicines Agency
EOP2: End of Phase 2 (Meeting)
FDA: Food and Drug Administration
FDAMA: FDA Modernization Act of 1997
GAIN: Generating Antibiotics Initiatives Now GDUFA: Generic Drug User Fee Act
G(X)P: Good (X = Clinical, Laboratory, or Manufacturing) Practice
ICH: International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use
IDP: Integrated Development Plan
IMP: Investigational Medicinal Product
IMPD: Investigational Medicinal Product Dossier
IND: Investigational New Drug (Application)
IRB: Institutional Review Board
MAA: Marketing Authorisation Application
MS: Member States (of European Union)
NIH: National Institutes of Health
NME/NCE: New Molecular/Chemical Entity
NSF: National Science Foundation
OIG: Office of the Inspector General
OTC: Over the Counter (Medicine)
PI, PII, PIII, PIV: Phase 1,2,3,4
PBMC: Peripheral Blood Mononuclear Cells
PDUFA: Prescription Drug User Fee Act
PIPs: Paediatric Investigation Plans
POM: Prescription Only Medicine
PRAC: Pharmacovigilance Risk Assessment Committee
QT: A Cardiac Conduction Interval
REMS: Risk Evaluation and Mitigation Strategy
SAP: Statistical Analysis Plan
SAWP: Scientific Advice Working Party
SOP: Standard Operating Procedure
SPA: Special Protocol Assessment