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Glossary List

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120-day Safety Report
30-day Hold
Abbreviated New Drug Application (ANDA)/505 (j) pathway 
Abnormal Use
Absorption, Distribution, Metabolism and Excretion (ADME) 
Acceptance Criteria
Acceptance Quality Level (AQL)
Access Consortium Procedure
Act on an application
Active Pharmaceutical Ingredient (API)
Active Therapeutic Device
Adaptive Pathways
Advanced Therapy Medicinal Product (ATMP)
Adverse Clinical Event (ACE)
Adverse Device Effect (ADE)
Adverse Drug Reaction (ADR)
Adverse Effect (AE)
Adverse Event (AE)
Adverse Event Reporting System (AERS) 
Affordability
Amendment
Analytical Data Model (ADaM)
Annual Report
Anonymization
Anonymization Report (AR)
Anonymized Data
Antimicrobial Resistance (AMR)
Applicant for Clinical Trial Applications (CTA)
Appropriately Reduce (risk)
Approval History
Assay
Audit
Audit by FDA
Bacteriophages (phages)
Bioavailability
Bioequivalence
Biologic License Application (BLA)
Biological Product
Biometric data
Biosimilars
Boxed Warning
Breakthrough Designation
Breakthrough Device Designation
Briefing Book (or briefing materials)
Carers 
Case Report Form (CRF)
CDER NextGen Portal
CE Marking
CE-Marking Technical File
Center for Biologics Evaluation and Research (CBER) 
Center for Devices and Radiological Health (CDRH)
Center for Drugs Evaluation and Research (CDER)
Centre of Veterinary Medicine (CVM)
Changes Being Effected in 0 Days (CBE-0)
Changes Being Effected in 30 Days (CBE-30)
Chemistry, Manufacturing, and Control (CMC)
China Marketing Authorization Holder (MAH)
China’s Center for Drug Evaluation (CDE)
Chinese Pharmacopoeia (ChP)
CIOMS I Form
Class I device
Class II device
Class III device
Clearance
Clinical Evaluation Report (CER)
Clinical Hold
Clinical Impact
Clinical Study Report (CSR)
Clinical Trial Application (CTA)
ClinicalTrials.gov identifier (NCT number) 
ClinicalTrials.gov 
CND (and EMDN)
Code of Federal Regulations (CFR) 
Combination product
Commercially Confidential Information (CCI)
Committee for Advanced Therapy (CAT)
Common Technical Document (CTD)
Company Core Data Sheet (CCDS)
Company Core Safety Information (CCSI)
Comparability Protocol
Comparability Study
Comparative Effectiveness Analysis (CEA)
Comparative Effectiveness Research (CER)
Compassionate Use
Competent Authority
Complete Response Letter (CRL)
Complete Review
Complex Generic
Conditional Marketing Authorisation
Confidentiality Regarding Participants
Consent
Consolidated Parallel Consultation
Contract Manufacturer
Contract Research Organization (CRO)
Control Group
Controlled Correspondence
Controlled Trial
Core Reimbursement Dossier
Core Value Dossier
Coronavirus Aid, Relief, and Economic Security Act (CARES Act)
Cost-Effectiveness
Critical Process Parameter (CPP)
Critical Quality Attribute (CQA)
Crossover Trial
Current Good Manufacturing Practice (cGMP)
CVM e-submitter
DailyMed
Data and Safety Monitoring Board (DSMB)
Data lock point (DLP)
Data Protection Impact Assessment (DPIA)
Data Protection Officer (DPO)
Data Protection Representative (DPR)
Data Universal Numbering System (DUNS) Number
De Novo
Design Controls
Development international birth date (DIBD)
Development safety update report (DSUR)
Device Deficiency
Device History File (DHF)
Device History Record (DHR)
Device master record (DMR)
Device User Facility
Digital Therapeutics (DTx)
Direct Healthcare Professional Communication (DHPC)
Discipline Review Letter (DRL)
Disease Risk-factor Reduction Claims (RDRC)
Double-blind research design
Double-blind, randomized, controlled clinical trial
Drug Delivery
Drug Efficacy Study Implementation (DESI)
Drug Listing
Drug Master File (DMF)
Drug Recall
Drug Withdrawal
Drugs@FDA
Dysbiosis
Dysfunction
Early Communication about an Ongoing Safety Review
Early Dialogues Committee (EDC)
Early Dialogues Working Party (EDWP)
Effectiveness
Efficacy
Efficacy-Effectiveness Gap
Electronic Drug Registration and Listing System (eDRLS)
EMA HTA Parallel Scientific Advice
Emerging Safety Issue
End of Trial (EoT) Declaration
End-of- Phase 1 (EOP-1)
End-of- Phase 2 (EOP-2)
Endpoint
Environment Scanning
Environmental Risk Assessment (ERA)
Establishment Registration
Ethics Committee (EC)
eTMF/ TMF: electronic Trial Master File / Trial Master File
EU Joint Clinical Assessment (JCA)
EU Reference Date
EUDAMED
EudraCT Form
European Directorate for the Quality of Medicines (EDQM)
European Medicines Agency (EMA)
European Network for Health Technology Assessment (EUnetHTA)
European Union (EU) Legal Representative
Expanded Access
Expected Life of a Device
Expectedness
Expedited Criteria
Experiment
Experimental Group
Expiration Date/Shelf Life
EXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)
Failure Mode, Effects and Criticality Analysis (FMECA)
Falsified Medicinal Product
FDA Adverse Event Reporting System (FAERS)
FDA Establishment Identifier (FEI) Number
FDA Form 483
FDA Pre-Submission Program
Fecal Microbiota Transplant (FMT)
Federal Register (FR)
Federal Trade Commission (FTC)
Field Safety Corrective Action (FSCA)
Field Safety Notice (FSN)
Follow-up Reporting
Food and Drug Administration (FDA or USFDA)
Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907
Foods for Special Medical Purpose (FSMP)
Form FDA 1571
Form FDA 1572
Form FDA 3500 (Medwatch Forms for FDA safety reporting)
Form FDA 356h
Form FDA 3674
Form FDA 3926
Form FDA 3938
Formal Dispute Resolution – NDA
Formal Meetings with FDA
GDPR / General Data Protection Regulation
Gene Therapy
General Investigational Plan (GIP)
Generic Drug
Generic Drug User Fee Amendments/Act (GDUFA)
Genetically modified micro-organism (GMM)
Genetically modified organism (GMO)
GMDN – Global Medical Device Nomenclature.
Good Clinical Practice (GCP)
Good Documentation Practices (GDPs)
Good Laboratory Practices (GLP)
Good Manufacturing Requirements (GMP)
Good PharmacoVigilance Practices (GVP) for the European Union
Hatch-Waxman act
Health Economic Model
Health Economics and Outcomes Research (HEOR)
Health Technology Assessment
Health Technology Assessment Bodies (HTABs)
Healthy volunteer
Human Factors Studies
Identified risk
IEC 62304
Immunoassay
Immunology
Important identified risk and Important potential risk
Important Missing Information
In Silico
In Vitro
In Vitro Diagnostic (IVD)
In Vitro Diagnostic Medical Device (IVDMD)
In vivo
In-patient
In-vitro Diagnostic Medical Device (IVD) Assay
Incident for IVDMD (IVDR definition)
Incident for Medical Device (MEDDEV definition)
Inclusion/exclusion criteria
IND
Independent Data Monitoring Committee (IDMC)
Indication
Individual Case Safety Report (ICSR)
Individual Parallel Consultation
Individual Patients 
Information Amendment
Information Request (IR)
Informed Consent Form (ICF)
Initial Reporting
INitial Targeted Engagement for Regulatory Advice (INTERACT) meeting
Innovation Meeting
Innovative Licensing and Access Pathway (ILAP)
Innovative Medicine
Institutional Review Board (IRB)
Integrated summary of efficacy (or effectiveness) (ISE)
Integrated summary of Safety (ISS)
International Birth Date (IBD)
International Committee for Harmonisation (ICH)
International Organization for Standards (ISO)
Investigational Device Exemption (IDE)
Investigational Drug
Investigational Medicinal Product Dossier (IMPD)
Investigational New Drug (IND)
Investigational New Drug Inactivation 
Investigational New Drug Withdrawal
Investigator
Investigator’s Brochure
ISO 13485
ISO 14155
Justification Table
Label
Labeler
Labeler Code
Labeler Code Request
Labeling
Large Volume Parenteral (LVP)
Lay Person Summary (of a clinical trial)
LCM (Life Cycle Management)
Letter of Authorization (LoA)
Listed Side Effect
Live Biotherapeutic Products (LBP)
MA (Marketing Authorisation)
Manual of Policies and Procedures (MaPP)
Manufacturer
Market Exclusivity
Market Protection
Market/patient Access
Marketing Authorization Application (MAA)
Markov Model
Material Safety Data Sheet (MSDS)
Medical Device
Medical Device (MDR definition)
Medical Device Report (MDR)
Medical Device Software
Medication error
MedWatch
Micro-organism
Microbiome
Minimal Risk
Misbranding
Missing information
Misuse of a medicinal product
Misuse of a medicinal product for illegal purposes
Module 3
Molecular compound
Monitoring Plan
Name Patient Use
National Cancer Institute - (NCI)
National Drug Code (NDC)
National Formulary (NF)
National Institutes for Food and Drug Control (NIFDC)
National Institutes of Health (NIH)
National Medical Products Administration (NMPA)
Natural History Studies
New Chemical Entity (NCE)
New Drug Application (NDA)
New Molecular Entity (NME)
No Action Indicated (NAI)
Non-substantial Amendment
Nonprescription Drug Label (“Drug Facts”)
Notified Body
Occupational exposure to a medicinal product
Off-label use
Office of the Commissioner (OC)
Open Label Study/Open Study
Orange book
Orphan Drug Designation (ODD)
Outcome
Outpatient
Over-the-Counter Drugs (OTC)
Overdose
Paediatric Investigation Plan (PIP) / Paediatric Study Plan (PSP)
Paragraph IV filing
Parallel Consultation (PC)
Parallel Distribution
Partial Clinical Hold
Patent
Patient Advocates
Patient Centricity
Patient Engagement
Patient Experts
Patient Information Leaflet (PIL)
Patient Organization Representatives
Patient Package Insert (PPI)
Patient Perspective
Patient Registry
Patient Reported Outcome (PRO)
Pediatric Exclusivity (PDE)
Periodic Adverse Drug Experience Report (PADER)
Periodic Safety Update Report (PSUR)
Periodic Summary Reporting
Personal Data
Phage therapy medicinal products (PTMPs)
Pharmaceutical Equivalents
Pharmaceutical Establishment License (PEL)
Pharmacovigilance
Pharmacovigilance System Master File (PSMF)
Phase I
Phase II
Phase III
Phase IV
Placebo
Placebo Effect
PMCF study
Positron Emission Tomography (PET) products
Post-Approval Change Management Protocol (PACMP)
Post-Authorization Efficacy Study (PAES)
Post-Authorization Safety Study (PASS)
Post-Market Clinical Follow-up (PMCF) plan
Post-Market Commitments (PMC)
Post-Market Requirements (PMR)
Post-Market Surveillance
Postbiotics
Potency
Potential risk
Pre-Clinical Data
Pre-IND Meeting
Pre-Market Approval (PMA)
Pre-Market Notification (510(k))
Pre-Submission Meeting
Prebiotic
Prescription Drug Product
Prescription Drug User Fee Act (PDUFA)
Principal Investigator (PI)
Prior Approval Supplement (PAS)
Priority Medicines (PRIME)
Priority Review
Probiotics
Product Specific Guidance
Project Management Plan
Propriety Name Review
Protection of Personal Data (PPD)
Protocol Amendment
Protocol Assistance (PA)
Pseudonymization
Qualified Person (QP)
Qualified Person for PharmacoVigilance (QPPV)
Quality Overall Summary (QOS)
Quality System Regulation (QSR)
Quality-by-Design(QbD)
Randomization/Random Assignment
Randomized Controlled Trial (RCT)
Real World Data (RWD)
Real World Evidence (RWE)
Real World Study (RWS)
Redaction
Reference Listed Drug (RLD)
Reference safety information
Refusal to File (RTF)
Refuse to Receive (RTR)
Regenerative Medicine Advanced Therapy Designation (RMAT)
Regulatory Authority (RA)
Remove Clinical Hold (RCH)
Request for Designation (RFD)
Review
Risk Management Plan (RMP)
Risk minimization measure
Risk-benefit balance
Safety concern
Safety Data Exchange Agreement (SDEA)
SaMD / SiMD
Scale-up
Scale-up and Post Approval Changes (SUPAC)
Scientific Advice
Section 505b(2)
Section 510(k)
Section 513(g)
Sensitive Data
Serious (Public) Health Threat
Serious Adverse Device Effect (SADE)
Serious Adverse Event (SAE)
Serious incident (MDR definition)
Signal
Signal Detection
Significant risk device
Single-blind research design
Somatic-Cell Therapy medicinal Products (sCTP)
SOUP
Special Protocol Assessment (SPA)
Specification
Sponsor
Standard Exchange of Nonclinical Data (SEND)
Standard of Care
Standard treatment
Starting Material (SM)
Statistical analysis plan (SAP)
Structured Product Labeling (SPL)
Study Data Tabulation Model (SDTM)
Study design
Substance Registration System (SRS)
Substantial Amendment (SA)
Suitability Petition
Summary of product characteristics (SmPC)
Supplement
Supplemental New Drug Application (sNDA)
Surrogate end point
Suspected Unexpected Serious Adverse Reaction (SUSAR)
Target Product Profile (TPP)
Technology Transfer
Tentative approval letter
The Reagan-Udall Foundation
Therapeutic Equivalence (TE) Codes
Tissue Engineered Product (TEP)
Trend reporting
Type A Meeting
Type B Meeting
Type C Meeting
Type D Meeting
UDI – Unique Device Identifier
Unanticipated Adverse Device Effect (UADE)
Unanticipated death or unanticipated serious injury
Unanticipated Serious Adverse Device Effect (USADE)
Unexpected adverse reaction
United States Agent
United States Patent and Trademark Office (US PTO)
United States Prescribing Information (USPI)
Use error
Validation
Value Proposition
Veterinary Master File (VMF)
Voluntary Harmonization Procedure (VHP)
Warning Letter
Written Responses Only

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