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
SPC: Summary of Product Characteristics
Author
Emily Burke, PhD has worked in biopharma for 20 years, gaining science writing experience at The Scripps Research Institute and Ionis Pharmaceuticals. As a Ph.D. molecular biologist, she is passionate about advancing the public’s understanding of science. In addition to being a self-proclaimed “science geek,” she is regularly asked to speak at international scientific meetings. When not teaching and writing the WEEKLY for Biotech Primer, Dr. Burke swims with her swim club and performs regularly on the improv circuit in San Diego.
