The Book of Jargon® – Healthcare & Life Sciences is one in a series of practice area and industry-specific glossaries published by Latham & Watkins.
The definitions provide an introduction to each term and may raise complex legal issues on which specific legal advice is required. The terms are also subject to change as applicable laws and customary practice evolve.
This glossary is intended to be a useful tool for recent law and business school graduates as well as other professionals seeking initiation into the industry, while also serving as a resource for seasoned executives.
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The information contained herein is not legal advice and should not be construed as such.
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3A List,3B Statement,3C Statement,30 month stay,340B Drug Pricing Program,351(k) Pathway,505(b)(2),510(k) Premarket Notification (510(k) Submission),8 + 2 + 1 (EU Data and Market Exclusivity),AAC,Abbreviated Biologics License Application (aBLA),Abbreviated New Drug Application (ANDA),aBLA,Ablation,ACA,Accelerated Approval,Accessory,Accountable Care Organization (ACO),Accreditation,ACE,ACE Inhibitors,ACO,Active Implantable Medical Devices (AIMDs),Active Moiety,Active Pharmaceutical Ingredient (API),Active Substance Master File (ASMF),Acute Lymphocytic Leukemia (ALL),Acute Myeloid Leukemia (AML),Adequate and Well-Controlled Clinical Trial,ADME,ADR,Adulterated Product,AdvaMed,AdvaMed Code,AdvaMed Code of Ethics on Interactions with Health Care Professionals (AdvaMed Code),Advanced Medical Technology Association (AdvaMed),Advanced Therapy Medicinal Products (ATMPs),Adverse Drug Reaction (ADR),Adverse Event (AE),Advertising,Advisory Committee,Advisory Opinion,AE,AEMPS,Affordable Care Act (ACA),Age-Related Macular Degeneration (AMD),AIFA,AKS,ALL,Allele,Allogenic,Ambulatory Payment Classification (APC),Ambulatory Surgery Center (ASC),Amino Acid,Amplification,Anatomical Therapeutic Chemical (ATC) Codes,ANDA,Anesthesia,Angiogenesis,Angiotensin-Converting Enzyme (ACE),Animal and Plant Health Inspection Service (APHIS),ANSM,Antibacterials,Antibiotic and Antibiotic Resistance,Antibody/Antibodies,Antibody Construct,Anticipation,Antigen,Anti-Kickback Statute (AKS),Antisense DNA,Antisense RNA,Antitrust Statutes,Antivirals,APC,APHIS,API,Applicable GPO (Sunshine Act),Applicable Manufacturer (Sunshine Act),Arrhythmia,Arzneimittel-zulassung,ASC,ASMF,ASP,Assay,ATMPs,Authorized Representative,Autologous,AUC / Area Under the Curve,Average Acquisition Cost (AAC),Average Manufacturer Price (AMP),Average Sales Price (ASP),BAA,Bacteria,Basal and Squamous Cell Skin Cancer,Bayh-Dole,B-Cell,Beneficiary,Beneficiary Inducement,Best Price,BfArM,Biotechnology Innovation Organization (BIO),Benign,Bioassay,Biocatalyst,Bioinformatics,Biological Product (Biologic),Biological Target,Biologics License Application (BLA),Biologics Price Competition and Innovation Act (BPCIA),Biomanufacturing,Biomarker,Biosimilar / Biosimilar Product,Biosimilar Product Applicant,Biological Product Sponsor,Biotechnology,BLA,Bispecific Antibodies,Blockbuster Drugs,Blood Brain Barrier (BBB),Bovine Spongiform Encephalopathy (BSE),BPCIA,BPCIA Exchange,Brand Name Drug,Branded Company (Branded Pharmaceutical Company),Breakthrough Therapy,BsUFA (Biosimilar User Fee Act) Date,Bulk Product / Bulk Ware,Business Associate,Business Associate Agreement (BAA),Business Combination,Cmax,Capsid,CAR,Carcinogenicity,Cardiac Arrest,Cardiology,Cardiomyopathy,CAR T-Cell,Cas,CAT,Catheter,CDC,CDR(s),CDRH,CE Marking,Cell,Cell Bank,Cell Line,Center for Biologics Evaluation and Research (CBER),Center for Devices and Radiological Health (CDRH),Center for Drug Evaluation and Research (CDER),Centers for Disease Control and Prevention (CDC),Centers for Medicare & Medicaid Services (CMS),Central Authorization of Medicinal Products in the European Union,Central Nervous System (CNS),Central Reexamination Unit (CRU),Centralised Procedure,CEP,Certification,Certification of Suitability of Monographs of the European Pharmacopoeia (CEP),Checkpoint Inhibitor,Chemistry, Manufacturing, and Controls (CMC),Children’s Health Insurance Program (CHIP),Chimeric Antigen Receptor (CAR),China Food and Drug Administration (CFDA),CHIP,CHMP,Chromosome,Chronic Lymphocytic Leukemia (CLL),Chronic Myeloid Leukemia (CML),Chronic Myelomonocytic Leukemia (CMML),Chronic Obstructive Pulmonary Disease (COPD),CID,CIP,Civil Investigative Demand (CID),Claim Chart,Claim Construction,Class I Medical Device,Class II Medical Device,Class III Medical Device,CLFS,CLIA,Clinical Data of a Device,Clinical Investigation Plan (CIP),Clinical Laboratory Improvement Amendments (CLIA),CLIA Certification,Clinical Development Safe Harbor / 271(e) Safe Harbor,Clinical Laboratory Fee Schedule (CLFS),Clinical Superiority,Clinical Trial,Clinical Trial Exemption (CTX),Clinical Trials Registry or ClinicalTrials.gov,CLL,Clone or Cloning,Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR),CMC,CML,CMML,CMS,Co-Branding,Co-Marketing,Co-Promotion,Coding,COGS,Coinsurance,Collaboration Agreement,Collagen,Combination Product,Commercial Reasonableness,Commercial Success,Commercialization,Commercially Reasonable Efforts,Committee for Advanced Therapies (CAT),Committee for Medicinal Products for Human Use (CHMP),Committee for Orphan Medicinal Products (COMP),Committee for Veterinary Medicinal Products (CVMP),Committee on Herbal Medicinal Products (HMPC),COMP,Companion Diagnostic,Compassionate Use,Competent Authorities of the Member States of the EEA,Competing Product,Complementary Determining Region (CDR),Complete Response Letter,Compliance Program Guidance (OIG),Composition of Matter,Conditional Marketing Authorisation (CMA),Confidential Disclosure Agreement,Confidential Information,Confidentiality Agreement,Conforming/Non-Conforming,Congenital Heart Disease,Contingent Value Rights (CVR),Continuations,Continuations in Part,Contract Research Organization (CRO),Control, Controls or Controlled,Cooperative Research and Development Agreement (CRADA),Coordination Group for Mutual Recognition and Decentralised Procedures (human/veterinary) (CMDh/v),Copayment,COPD,Corporate Integrity Agreement (CIA),Corporate Practice of Medicine,Cosmeceuticals,Cost of Goods Sold (COGS),Covenant Not to Sue,Cover, Covering or Covered,Coverage,Covered Drug, Device, Biological or Medical Supply (Sunshine Act),Covered Entity,Covered Recipient (Sunshine Act),CPT CODE,CRISPR,CRISPR-Cas9,Cross License,Cross-Walking,CRU,CTX,Current Procedural Terminology Code (CPT Code),Custom-Made Device,CVMP,Cytokine,Cytology,Data,Data Breach,Data Safety Monitoring Board,De novo Classification,Decentralised Procedure,Declaration of Helsinki Procedure,Declaratory Judgment,Deductible,Deferred Prosecution Agreement (DPA),Definiteness,Deoxyribonucleic Acid (DNA),Derivation Claim,Dermal,Dermatology,Designated Health Services (DHS),Development,Development Costs,Device / Medical Device,Device Intended for Clinical Investigation,Device Master File,DHS,Diagnosis Code,Diagnosis Related Groups (DRGs),Diagnostic,Diagnostic Kit,Dialysis,Diligence,Diligent Efforts,Discount/Rebate,Divisionals,DME,DMEPOS Competitive Bidding Program,DNA,Doctrine of Equivalents,Domain Name,Dosage Form,Drug,Drug Development,Drug Discovery,Drug Master File,Drug Price Competition and Patent Term Restoration Act,Drug-Eluting Stent,Dual Eligible Beneficiaries,Durable Medical Equipment (DME),E. coli, or Escherichia coli,EAP / Expanded Access Program,Ear, Nose and Throat (ENT),Earn-out,EDMA,EDMA Code,EDQM,EFPIA,EFPIA Code,Electrocardiogram (EKG),Elements to Assure Safe Use (ETASU),EMA,Embryology,Embryonic Stem Cells,Enablement,Encumbered,End-of-Phase I Meeting,End-of-Phase II Meeting,Endogenous,Endoscopy,Enforcement Discretion,Enzyme,Epidemiology,Epigenetics,Erythropoietin,Ethics Committee,Etiology,EU,EU Data Protection Directive,Eucomed Code,Eukaryote,European Directorate for the Quality of Medicines & HealthCare (EDQM),European Drug Master File (EDMF),European Economic Area (EEA),European Federation of Pharmaceutical Industries and Associations (EFPIA),European Medicines Agency (EMA),European Patent Office (EPO),European Public Assessment Report (EPAR),Examiner,Excipient,Excluded Parties List System,Exclusion from Program,Exclusive Provider Organization (EPO),Exclusivity,Fab Fragment,Fair Market Value,False Claim / False or Fraudulent Claim,False Claims Act (FCA),FAR,Fast Track Product,FBMC,Fc Region,FCA,FCA / Free Carrier Alongside (Incoterms),FCPA,FDA,Federal Acquisition Regulations (FAR),Federal Circuit,Federal Food, Drug, and Cosmetic Act (FDCA),Federal Health Care Programs (FHCP),Federal Institute for Drugs and Medical Devices or Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM),Federal Supply Schedule (FSS),Federal Trade Commission (FTC),Fee Splitting,Fee-for-Service (FFS),Femoral Catheterization,Field,Fill & Finish,First Commercial Sale,First to Invent (FTI),Flow Cytometry,Fluorescence-activated Cell Sorting (FACS),Follow-on Biologic,Food and Drug Administration Safety and Innovation Act (FDASIA),Force Majeure,Foreign Corrupt Practices Act (FCPA),Form 483,Formulary,Formulary Tier,Formulation,Fraud and Abuse (F&A),Free Sales Certificate,FTE,FTE Costs,FTE Rate,FTI,Full-Time Equivalent,Fully Burdened Manufacturing Costs (FBMC),Fully Integrated Medical Group (FIMG),GAAP,GAIN Act,Gapfilling,Gastrointestinal Stromal Tumor (GIST),Gene,Gene Expression,Gene Fragment,Gene Synthesis,Gene Therapy,Generally Accepted Accounting Principles (GAAP),Generic Drug or Generic Product,Generic Product Applicant,Genetic Engineering,Genetic Variation,Genetically Modified Organism (GMO),Genetics,Genome,Genome Sequencing,Genomics,Genotype,Geriatrics,Gerontology,GIST,Glaucoma,Glucose Monitoring,GMO,Good Clinical Practices (GCP),Good Clinical Practices (GCP) Inspection Findings,Good Distribution Practice (GDP),Good Faith Negotiations,Good Laboratory Practices (GLP),Good Manufacturing Practices/Current Good Manufacturing Practices (GMP/cGMP),Good Pharmacovigilance Practice (GVP),Governmental Authority,GPO,Graham Factors,Group Contract,Group Model HMO,Group Purchasing Organization (GPO),Gynecology,Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR),Hatch-Waxman Act,HCPCS,HCPCS Code,Health and Human Services (HHS),Health Claims Act,Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH),Health Insurance Portability and Accountability Act (HIPAA),Health Maintenance Organization (HMO),Healthcare Professional / Healthcare Practitioner (HCP),Hematology,Heterogeneous,HHS,HIPAA,HIPAA Breach,HIPAA Breach Notification Rule,HIPAA Omnibus Final Rule,HIPAA Privacy Rule,HIPAA Security Rule,HMPC,Hodgkin’s Disease,Hospital Outpatient Prospective Payment System (OPPS),Howard Hughes Medical Institute (HHMI),Human Leukocyte Antigens (HLA),Hybrid Marketing Authorisation Application,Hyperkalemia,Hyperphosphatemia,Hypertension,ICH,ICH Guidelines,ICH Regulatory Party,IFRS,Immunology,Immuno-oncology,Immunotherapy,In Silico,In Vitro,In Vitro Diagnostic (IVD),In Vitro Diagnostic Medical Device,In Vivo,Incident,Incoterms,IND,IND Enabling Studies,Independent Review Organization (IRO),Indication,Induced Pluripotent Stem Cells (iPSCs),Inducement,Inflammation,Infringement,Institutional Review Board (IRB),Intellectual Property,Inter Partes Review (IPR),Intercellular,Interchangeable Biologic,Interference Proceeding,International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH),International Financial Reporting Standards (IFRS),International Non-Proprietary Names (INNs),Intervened Case,Intracellular,Intravenous (IV),Invention,Investigational New Drug Application (IND),In-vitro Fertilization (IVF),IPR,Italian Medicines Agency or Agenzia Italiana del Farmaco (AIFA),Japanese Ministry of Health, Labour and Welfare (MHLW),J-Code,JDC,Joint Commercialization Committee (JCC),Joint Commission,Joint Development Committee (JDC),Joint Invention,Joint Steering Committee (JSC),Kaplan-Meier,Key Opinion Leader (KOL),Kickback,Know-How,Label,Labeling,Laboratory Developed Test (LDT),Large Molecule Drug,Latham & Watkins,Lauer-Taxe (Germany),LDT,Leahy-Smith America Invents Act,Legal Privilege,Leukemia,Leukocytes,License,License Fee,Licensed Know-How,Licensed Patents,Licensed Product,Licensor,Ligand,Lipid,List of Excluded Individuals and Entities (LEIE) Database,Local Coverage Determination (LCD),Lock Ups,Lymphoma,Magnetic Resonance Imaging (MRI),Major Histocompatibility Complex (MHC),Malignant,Management Services Organization (MSO),Manufacturer,March-in Rights,Marketing Authorisation Application (MAA),Markman,Mass Spectrometry (MS),Master Batch Record / Batch Record,Master Cell Bank,Maximum Tolerated Dose (MTD),Mayo,Means-Plus-Function,Mechanism of Action,Medicaid,Medicaid Drug Rebate Program,Medical Device,Medical Necessity,Medicare,Medicare Access and Chip Reauthorization Act Of 2015 (MACRA),Medicare Administrative Contractor (MAC),Medicare Part A,Medicare Part B,Medicare Part C (Medicare Advantage),Medicare Part D,Medicare Payment Advisory Commission (MedPAC),Medicare Physician Fee Schedule,Medicare Shared Savings Program,Medicines and Healthcare Products Regulatory Agency (MHRA),Medizinisches Versorgungs-zentrum (MVZ) (Medical Care Center) (Germany),MedTech Code,Melanoma,Mesothelioma,Messenger RNA (mRNA),Metastasize,Methylation of DNA,Microbiome,Micro-RNAs,Milestone,Ministry of Food and Drug Safety (MFDS),Milestone Payment,Misbranded Product,Mitochondria,MolDx,Molecular Diagnostic Services (MolDx) Program,Molecular Diagnostics / Molecular Diagnostic Tests,Molecule,Monoclonal,Monoclonal Antibody,Monogenic Disease,Most Favored Nation (MFN) Provision,mRNA,Multiple Ascending Dose (MAD),Multiple Myeloma,Mutation,Mutual Recognition Procedure,Myocardial Infarction (MI),Myriad,Nanotechnology,National Agency for Medicine and Health Products Safety or Agence Nationale de Sécurité de Médicament et des Produits de Santé (ANSM),National Cancer Institute (NCI),National Coverage Determination(NCD),National Health Surveillance Agency of Brazil (ANVISA),National Institutes of Health (NIH),National Provider Identifier,Needs Assessment,Neoantigens,Neoplasm,Net Sales,Neuroblastoma,Neurology,Neuropathy,Neuroscience,New Chemical Entity (NCE) Exclusivity,New Molecular Entity (NME),New Technology APC,NIH,Non-Clinical,Non-Compete,Non-Disclosure Agreement,Non-Hodgkin’s Lymphoma,Notice of Commercial Marketing,Notified Bodies,Novelty,Nucleotides,Nutraceuticals,Obstetrics,Obviousness,Office of the Inspector General (OIG) of HHS,Off-Label Promotion,OIG,Oligonucleotide,Oligonucleotides,Opposition (Patent),Opthalmology,Optogenetics,Orange Book Listing,Org Meeting / Organizational Meeting,Orphan Designation,Orphan Disease,Orphan Drug / Orphan Medicinal Product,Orphan Exclusivity,Orthopedics,Osteoarthritis (OA),Out-of-Network,Overpayment,Paediatric Committee (PDCO),Paediatric Investigation Plan (PIP),Paragraph IV,Parallel Import Restrictions,Pass-Through Payment Status / Transitional Pass-Through Payment Status,Patent,Patent Dance,Patent Term Extension,Patent Trial and Appeal Board (PTAB),Patentable Subject Matter,Pathology,Patient Assistance Programs (PAPs),Patient Registry,Paul-Ehrlich-Institut,Pay for Delay,PCR,PCSK9,PDCO,Pediatrics,Peptide,Performance Standards,Periodic Safety Update Report (PSUR),Peripheral Artery Disease,Person of Ordinary Skill / Person Having Ordinary Skill in the Art,Personal Data,Personalized Medicine,Pharmaceutical,Pharmaceutical Research and Manufacturers of America (PhRMA),Pharmacodynamics (PD),Pharmacogenomics,Pharmacokinetics (PK),Pharmacology,Pharmacovigilance,Pharmacovigilance Risk Assessment Committee (PRAC),Pharmacy & Therapeutics Committee (P&T Committee),Pharmacy Benefit Manager (PBM),Phase I Clinical Trial,Phase II Clinical Trial,Phase III Clinical Trial,Phase IV Clinical Trial,Phenotype,PHI,Phillips Standard,PhRMA,PhRMA Code on Interactions with Health Care Professionals (PhRMA Code),PHSA,Physician Consulting Agreement,Physician Payment Sunshine Act,Physician-Owned Distributor (POD),Physiology,PIP,Pivotal Clinical Trial/Registration Trial,Placing on the Market,Plasmid,PMA,Points to Consider (PTC),Polygenic Disease,Polymer,Polymerase Chain Reaction (PCR),Post-Approval Commitment,Post-Market Clinical Follow-Up (PMCF),Post-Market Surveillance (PMS),Post-Marketing Commitments or Requirements (PMC/R),Post-Translational Modification,Precision Medicine,Pre-Clinical,Preclinical Studies,Pre-Emerging Biotechs,Pre-IND Meeting,Preliminary Injunction,Premarket Approval (PMA),Pre-NDA Meeting,Prescription (Rx),Prescription Drug User Fee Act Date (PDUFA Date),Pricing Approval,Principal Investigator,Prior Authorization,Priority,Priority Review,Priority Review Voucher,Private Payor,Prodrug,Product Insert / Instructions for Use,Product Labeling,Product Liability,Product Literature,Prokaryote,Promotional Materials,Proof of Concept,Prosecution,Prospective Payment System (PPS),Protected Health Information (PHI),Protecting Access to Medicare Act of 2014 (PAMA),Protein,Protein Engineering,Proteome,Proteomics,Providers,PTAB,Public Health Service Act (PHSA),Public vs. Private Health Insurance in Germany,Pulmonary,Purple Book,P-Value,Qualified Infectious Disease Product (QIDP),Qualified Person,Qualified Person Responsible for Pharmacovigilance (QPPV),Quality Agreement,Quality System Regulation (QSR),Qui Tam,Radiology,Rapporteur and Co-Rapporteur,Rare Disease,Rational Drug Design,Reagent,Recombinant DNA Advisory Committee (RAC),Reexaminations,Reference Listed Drug (RLD),Reference Medicinal Product / European Reference Product (ERP),Reference Product,Reference Product Sponsor,Registration Trial,Regulatory Approval,Regulatory Approval Application,Regulatory Authority,Regulatory Documentation,Regulatory Filing,Reimbursement,Reimbursement Support Services,Reissues,Relator,Remuneration,Representations and Warranties,Reverse Payment,Rheumatology,Ribonucleic Acid (RNA),Right of First Negotiation,Right of First Offer,Right of First Refusal (ROFR),Right of Reference,Risikoklassen Medizinprodukte (Classification of Medical Devices) (Germany),Risk Evaluation & Mitigation Strategy (REMS),RNA,RNA Interference,Rolling Forecast,Royalty,Safe Harbor,Sarcoma,Scientific Advice,Scientific Advice Working Party (SAWP),Scientific Advisory Board (SAB),Scientific Advisory Board (SAB) Member,Scientific Exchange,Secondary Considerations,Secondary Payor,Section (k),Self-Disclosure Protocol (SDP),Sensitive Personal Data,Sequestration,Serious Adverse Drug Experience,Serious Adverse Event (SAE),Serious Adverse Reaction (SAR),Service Mark,Sherman Antitrust Act,Short Interfering RNAs,Sicherheitsbe-auftragter (Safety Officer) (Germany),Similar Active Substance,Similar Medicinal Product,Single Ascending Dose (SAD),Single Nucleotide Polymorphism (SNP),Small Molecule Compound,Somatic Cell,Spanish Agency for Medicines and Health Products or Agencia Española de Medicamentos y Productos Sanitarios (AEMPS),Special Advisory Bulletin (HHS OIG),Special Fraud Alert (HHS OIG),Special Protocol Assessment (SPA),Specialty Pharma (SPEC Pharma),Specialty Pharmaceuticals,Specialty Pharmacy,Specifications,Standard Review,Stark Law,Stem Cells,Step Edits,Subcontractor (HIPAA),Subdermal,Sublicense,Sublicense Revenue,Sublicensee,Sublicensor,Subpoena,Substrate,Summary of Product Characteristics (SmPC),Supplement,Supplemental Medicare Plan,Suppliers,Suspected Unexpected Serious Adverse Reaction (SUSAR),Sustainable Growth Rate (SGR) Formula,Suture,Synthetic Biology,Synthetic DNA,Systems Biology,Target,Target Validation,T-Cell,TCR or T-Cell Receptor,Teaching Away,Technology Transfer,Telomerase,Telomeres,Territory,Therapeutic,Therapeutic Goods Administration (TGA),ThirdParty Administrator (TPA),Third-Party Payor,Tmax,Toxicology,Trade Secret,Trademark,Transcription,Transdermal,Transfer RNA (tRNA),Translation,Translational Research,Transparenzkodex Freiwillige Selbstkontrolle für die Arzneimittel-industrie e. V. (FSA) (Germany),Treble Damages,TRICARE Retail Pharmacy Program,TrOOP Costs,True Out-of-Pocket Costs,Type A Meeting,Type B Meeting,Type C Meeting,U.S. Food and Drug Administration (FDA),Ultrasound,Unexpected Serious Adverse Reaction (USAR),United States Patent and Trademark Office (USPTO),Unsolicited Request for Off-Label Information,Upcoding,Upstream Processing,Urology,Use of Proceeds,Vaccine,Vaccine Technology,Valid Claim,Vascular,Vector,Virology,Virus,Voluntary Disclosure,Wholesale Distributor,Working Cell Bank,Written Description,Yates Memo,New Drug Application (NDA),Licensee,Non-Small Cell Lung Cancer (NSCLC),Oncology