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ADME: Absorption, Distribution, Metabolism, Excretion

AE: Adverse Event

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

CNS: Central Nervous System

COG: Cost of Goods

COMP: Committee for Orphan Medicinal Products

CRA: Clinical Research Associate

CRF: Case Report Form

CRO: Clinical Research Organization, Contract Research Organization

CSF: Cerebrospinal Fluid

CTA: Clinical Trial Application

CVS: Cardiovascular System

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

GI: Gastrointestinal

G(X)P: Good (X = Clinical, Laboratory, or Manufacturing) Practice

HCP: Healthcare Professional

IB: Investigators Brochure

IC: Informed Consent

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)

IP: Intellectual Property

IPO: Initial Public Offering

IRB: Institutional Review Board

KOL: Key Opinion Leaders


LCM: Life Cycle Management

MAA: Marketing Authorisation Application

MAD: Multiple Ascending Dose

MCB: Master Cell Bank

MLR: Medical and Legal Review

MS: Member States (of European Union)

MSL: Medical Science Liaison

MTD: Maximum Tolerated Dose

MPP: Minimum Product Profile

MW: Molecular Weight

NDA: New Drug Application

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

P&L: Profit and Loss

PBMC: Peripheral Blood Mononuclear Cells

PD: Pharmacodynamic

PDCO: Paediatric Committee

PDUFA: Prescription Drug User Fee Act

PI: Principal Investigator

PIPs: Paediatric Investigation Plans

PK: Pharmacokinetic

RMP: Risk Management Plan

POC: Proof of Concept

POM: Prescription Only Medicine

PR: Public Relations

PRAC: Pharmacovigilance Risk Assessment Committee

QA: Quality Assurance

QC: Quality Control

QOL: Quality of Life

QT: A Cardiac Conduction Interval

R&D: Research and Development

REMS: Risk Evaluation and Mitigation Strategy

RMP: Risk Management Plans

ROA: Route of Administration

ROI: Return on Investment

SAD: Single Ascending Dose

SAE: Serious Adverse Event

SAP: Statistical Analysis Plan

SAWP: Scientific Advice Working Party

SOP: Standard Operating Procedure

SPA: Special Protocol Assessment

SPC: Summary of Product Characteristics

TA: Therapeutic Area

TPP: Target Product Profile

VBP: Value Based Pricing

WCB: Working Cell Bank

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