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SOPP 8401 Acronym List

Acronym CBER Usage
AC Advisory Committee
ADaM Analysis Data Model (a data standard)
ADRM Associate Director for Review Management
APLB Advertising and Promotional Labeling Branch (OCBQ)
BIMO Bioresearch Monitoring Program (OCBQ)
BIRAMS Biologics Investigational and Related Applications Management System
BITS-PTS Biologics Information Tracking System- Pre-Applications Module
BLA Biologics License Application
BPCA Best Pharmaceuticals for Children Act
CAB Consumer Affairs Branch
CBER Center for Biologics Evaluation and Research
CDISC Clinical Data Interchange Standards Consortium (a data standard)
CDTL Cross-Discipline Team Leader
CFR Code of Federal Regulations
CMC Chemistry, Manufacturing and Controls
CR Complete Response
CTB Communication Technology Branch (OCOD)
DAN DCC Action Notice
DAT Data Abstraction Team
DATS Document Accountability Tracking System
DBSQC Division of Biological Standards and Quality Control (OCBQ)
DCC Document Control Center
DCCA Division of Communication and Consumer Affairs (OCOD)
DDOM Division of Disclosure and Oversight Management (OCOD)
DIS Division of Inspections and Surveillance (OCBQ)
DMPQ Division of Manufacturing and Product Quality (OCBQ)
DR Discipline Review
EDR Electronic Document Room
EDT Electronic Disclosure Team (OCOD/DDOM)
E-FAP Electronic Final Action Package
EIR Establishment Inspection Report
ERG Eastern Research Group (contractor)
ESC Electronic Submissions Coordinator
Fax Facsimile
FDA Food and Drug Administration
FDAAA Food and Drug Administration Amendments Act
FD&C Federal Food, Drug, and Cosmetic Act
FDAMA Food and Drug Administration Modernization Act
FDASIA Food and Drug Administration Safety and Innovation Act (2012)
FMD Field Management Directive
GDUFA Generic Drug User Fee Act
GLP Good Laboratory Practices
GMP Good Manufacturing Practices
GRMP Good Review Management Principles and Practices (for PDUFA Products)
IR Information Request
LIB Laboratory of Immunobiochemistry Branch (OCBQ)
MDUFA Medical Device User Fee Act
MRP Managed Review Process
NCT National Clinical Trial
NDC National Drug Code
NDA New Drug Application
NME New Molecular Entity
OBE Office of Biostatistics and Epidemiology
OCBQ Office of Compliance and Biologics Quality
OCC Office of Chief Counsel (FDA)
OCOD Office of Communication, Outreach and Development (formerly OCTMA/CBER)
PDUFA Prescription Drug User Fee Act
PeRC Pediatric Review Committee (FDA)
PHS Public Health Service Act
PLR Physician’s Labeling Rule
PMC Postmarketing Commitment
PMR Postmarketing Requirement
PNR Proprietary Name Reviews
PRB Product Release Branch (CBER/OCBQ/DMPQ)
PREA Pediatric Research Equity Act
REMS Risk Evaluation and Mitigation Strategy
RIMS Regulatory Information Management Staff (CBER/OM)
RMS-BLA Regulatory Management System – Biologics License
RPM Regulatory Project Manager
RTF Refusal to File
SBRA Summary Basis of Regulatory Action
SDTM Study Data Tabulation Model (a data standard)
SOPP Standard Operating Procedure and Policy (CBER)
STN Submission Tracking Number
SWG Safety Working Group
TOC Table of Contents
UNII Unique Ingredient Identifier