SOCRA 2024 Annual Conference Program Book - Flipbook - Page 78
TERMINOLOGY
GCPP 3 Good Clinical Practices Program (in Office of
the FDA Commissioner)
GGP 3 Good Guidance Practices
GLP 3 Good Laboratory Practice
GMP 3 Good Manufacturing Practice (see QSR below)
HDE 3 Humanitarian Device Exemption
HF 3 Routing code for mail to the Office of the
Commissioner of the FDA
HFD 3 Routing code for mail to CDER
HFM - Routing code for mail to CBER
HFS 3 Routing code for mail to CFSAN
HFV 3 Routing code for mail to CVM
HFZ 3 Routing code for mail to CDRH
HIE- Health Information Exchange
HIPAA - Health Insurance Portability and
Accountability Act
HQ 3 Headquarters
HSP 3 Human Subject Protection
HUD 3 Humanitarian Use Device
IB - Investigator Brochure
IC 3 Informed Consent
IC / ICF / ICD - Informed Consent / Informed Consent
Form / Informed Consent Document
ICD 3 Informed Consent Document
ICF 3 Informed Consent Form
ICH 3 International Conference on Harmonisation of
Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH)
ICMJE 3 International Committee of Medical Journal
Editors
IDB / IB - Investigational Drug Brochure / Investigator
Brochure
IDE 3 Investigational Device Exemption
IEC 3 Independent Ethics Committee
IG 3 (Office of the) Inspector General
INAD 3 Investigational New Animal Drug
IND - Investigational New Drug (Application)
IRB 3 Institutional Review Board
IRC 3 Institutional Review Committee
ISO 3 International Organization for Standardization
IT 3 Information Technology
IVD 3 In Vitro Diagnostic
MedDRA- Medical Dictionary for Regulatory Activities
MDR 3 Medical Device Report (part of MedWatch)
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NAI 3 No Action Indicated (FDA inspection
classification)
NCI 3 National Cancer Institute
NCS - Not Clinically Significant
NDA 3 New Drug Application
NEJM 3 New England Journal of Medicine
NIDPOE - Notice of Initiation of Disqualification
Proceeding and Opportunity to Explain
NIH - National Institutes of Health, Health and Human
Services
NME 3 New Molecular Entity
NOOH 3 Notice of Opportunity for Hearing
NSR - Non-significant Risk (Devices)
OAI 3 Official Action Indicated (FDA inspection
classification)
OC 3 Office of Compliance or Office of the
Commissioner
OCC 3 Office of Chief Counsel
OCI 3 Office of Criminal Investigations
ODE 3 Office of Device Evaluation
OEI - Official Establishment Inventory
OGC 3 Office of General Counsel
OGD 3 Office of Generic Drugs
OHRP - Office for Human Research Protections
(Health and Human Services)
OIVD 3 Office of In Vitro Diagnostic Device Evaluation
and Safety
OMP 3 Office of Medical Policy CDER
OND 3 Office of New Drugs CDER
ORA 3 (FDA) Office of Regulatory Affairs
ORI 3 Office of Research Integrity
OTC - Over the Counter (non-prescription)
OTCOM 3 Office of Training and Communications
CDER
P&A 3 Promotion and Advertising
PDP 3 Product Development Protocol
PDUFA 3 Prescription Drug User Fee Act of 1992
PEB 3 Program Enforcement Branch
PI 3 Principal Investigator (in reference to Public
Health Service grant recipient)
PMA 3 Premarket Application
PMA 3 Premarket Approval Application
PMDA 3 Pharmaceutical and Medical Device Agency
(Japan)
