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Glossary
FDA 1572
FDA Statement of Investigator form.
All
A
B
C
D
E
F
G
H
I
L
M
N
O
P
Q
R
S
T
U
V
W
Abbreviated New Drug Application (ANDA)
Abridged Application
Active Pharmaceutical Ingredient (API)
Active Substance
Active Substance Master File (ASMF)
Adjuvant
Adverse Drug Reaction (ADR)
Adverse Event (AE)
Amendment
Analysis Data Model (AdAM)
Analysis Datasets
Anatomical Therapeutic Chemical Classification System (ATC)
Annotated Case Report Form
Annotated ECG waveform data
Annual Report
Applicant
Application Number
Approval Letter
ASEAN Common Technical Document (ACTD)
Biologic Product
Biologics License Applications (BLA)
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
CE Mark (CE)
Center for Biologics Evaluation and Research (CBER)
Center for Devices and Radiological Health (CDRH)
Center for Drug Evaluation and Research (CDER)
Centralised Procedure (CP)
Centrally-Authorised Procedure (CAP)
Certificate of Suitability (CEP)
Checksum
Chemical Abstracts Service Registry Number (CAS Number)
Chemistry, Manufacturing and Controls (CMC)
Clinical Data Interchange Standards Consortium (CDISC)
Clinical Trial Applications (CTA)
CMC Supplement
Code of Federal Regulations (CFR)
Commitment
Committee for Medicinal Products for Human Use (CHMP)
Common Technical Document (CTD)
Competent Authority
Complete Response Letter
Concerned Member State (CMS)
Controlled Vocabulary
Core Data Sheet (CDASH)
DailyMed
Data Definition File
Data Listings
Data Tabulation Datasets
Decentralised Procedure (DCP)
Define.xml
Device
Digital Application Dataset Integration (DADI)
Digital Signature
Document Type Definition (DTD)
Dosage Form
Dosage Strength
Drug Master File (DMF)
Drug Product (DP)
Drug Substance (DS)
eCopy
eCTD Backbone
eCTD Validation Criteria
Efficacy Supplement
Electronic Application Form (eAF)
Electronic Signature
Electronic Submissions Gateway (ESG)
Envelope
European Directorate for the Quality of Medicines (EDQM)
European Economic Area (EEA)
European Medicines Agency (EMA)
Excipient
eXtended EudraVigilance Medicinal Dictionary (XEVMPD)
eXtended EudraVigilance Product Report Message (XEVPRM)
Fast Healthcare Interoperability Resources (FHIR)
FDA 1571
FDA 1572
FDA 2253
FDA 356h
File Tag
Food and Drug Administration (FDA)
Generic Drug
Global Trade Item Number (GTIN)
Grouped Submission
Guidance
Gulf Co-operation Council (GCC)
Health Canada
ICH E3
Identification of Medicinal Products (IDMP)
Indication
Integrated Summary of Efficacy (ISE)
Integrated Summary of Safety (ISS)
Intermediate (or Intermediate Product)
International Council for Harmonisation (ICH)
International Nonproprietary Name (INN)
International Organization for Standardization (ISO)
Investigation New Drug Application (IND)
Investigational Medicinal Product Dossier (IMPD)
Investigator’s Brochure (IB)
Label
Labeling Supplement
Labelling
Leaf Element
Leaf Title
Lifecycle Operations
Manufacturing Supplement
Marketing Authorisation Application (MAA)
Marketing Authorisation Holder (MAH)
Medical Device
Medical Dictionary for Regulatory Activities (MedDRA)
Medicines and Healthcare products Regulatory Agency (MHRA)
Module 1
Module 2
Module 3
Module 4
Module 5
Mutual Recognition Procedure (MRP)
National Competent Authority (NCA)
Nationally Authorised Product (NAP)
New Drug Application (NDA)
Node Extension
Non eCTD Electronic Submission (NeeS)
Novel Excipient
Organisation Management Service (OMS)
Packaged Medicinal Product Identifier (PCID)
Patient Package Insert (PPI)
Pharmaceuticals and Medical Devices Agency (PMDA)
Pharmacopoeia
Pharmacovigilance Risk Assessment Committee (PRAC)
Plasma Master File (PMF)
Predicate Rule
President’s Emergency Plan for AIDS Relief (PEPFAR)
Priority Review
Qualified Person Responsible For Pharmacovigilance (QPPV)
Quality Overall Summary (QOS)
Rapporteur
Reference Listed Drug
Reference Member State (RMS)
Regulated Product Submissions (RPS)
Regulatory Activity
Regulatory Affairs
Regulatory Information Management System (RIM / RIMS)
Regulatory Intelligence
Related Sequence
Rolling Submission
Route of Administration
Sequence
Sequence Number
Signal Detection
Sponsor
Standard for Exchange of Nonclinical Data (SEND)
Statistical Analysis System (SAS)
Structured Product Labeling (SPL)
Study Data Tabulation Model (SDTM)
Study Tagging File (STF)
Subject Profiles
Submission
Substance, Product, Organization, Referentials (SPOR)
Summary of Product Characteristics (SmPC)
Supplement
Systemized NOmenclature of Medicine – Clinical Terms (SNOMED-CT)
Therapeutic Area
Trade Name
Unique Ingredient Identifier (UNII)
Universally Unique IDentifier (UUID)
Variation
Veterinary Non eCTD Electronic Submission (vNeeS)
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