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Last Updated Thursday, April 17 2014
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21 CFR Part 11
483 Letter
505 (b) (2) submission

Abbreviated Antibiotic Drug Application (AADA)
Abbreviated New Drug Application (ANDA)
Absorption, Distribution, Metabolism and Excretion/Toxicology (ADME/T)
Acceptable Daily Exposure (ADE)
Action Letter
Active Pharmaceutical Ingredient (API)
ADC
ADE
ADI
ADME/T
ADR
Adverse Drug Reaction (ADR)
Adverse Event (AE)
Aerosol
AFSSAPS
Agonist
Amino Acids
Ampoule (Ampule)
Analytical Data Interchange (ANDI)
Analytical Method
ANDA
Animal-Derived Ingredient (ADI)
ANSM
Antagonist
Antibiotic
Antibody
Antibody-Drug Conjugates (ADCs)
Antifungal
Antigen
Antimicrobials
Antisense
Antiseptic
API
Approval Letter
Aseptic Processing
Assay
Asymmetric Synthesis
Audit
Audit Trail
Aural (Auricular)
Authorized Person (AP)
Auto-Injector

Bacteria
Batch
Bead
BIO
Bio-Intermediate
Bioactivity
Bioanalysis (Bioanalytical)
Bioassay
Bioavailability
Bioburden
Biocatalysis
Biocatalyst
Biocide
Bioequivalence
Biogeneric
Bioinformatics
Biologic
Biological Pathway
Biologics License Application (BLA)
Biometrics
Biopharmaceutical
Bioprocess
Bioreactor
Biosafety in Microbiological and Biomedical Laboratories
Biosimilar
Biosynthesis
Biotechnology
Biotransformation
BLA
Blister Pack
Blocks
Blow (Form), Fill, Seal
BMBL
Bolus
Bovine Spongiform Encephalopathy (BSE)
BPC
British Pharmacopoeia (BP)
BSE
Bulk Pharmaceutical Chemical (BPC)

CAPA
Capacity Utilization
Capacity Utilization
Caplet
Capsule
Carbapenem
Carcinogenic
Case Report Form (CRF)
CBE
CBE 30
CBER
CDER
CDMO
Cell
Cell Banks
Cell Culture
Cell Lines
Cell Therapy
Center for Biologics Evaluation and Research (CBER)
Center for Drug Evaluation and Research (CDER)
Cephalosporins
CFR
cGMP
Change Control
Change Order
Changes Being Effected
Characterization
Chemical Library
Chemical Process Development
Chemical Synthesis and Scale-Up
Cheminformatics
Chemistry, Manufacturing, and Controls (CMC)
Chewable Tablet
Child Resistant (CR)
Chimera
Chinese Hamster Ovaries (CHO)
Chiral Compound
CHMP
CHO
Chromatography
Chromosomes
CIP
Class 1,000
Class 10,000
Class 100
Class 100,000
Clean In Place (CIP)
Cleanroom
Clinical Research Associate
Clinical Trials
Clone
Cmax
CMC
Cmin
CMO
Coated
Code of Federal Regulations, Title 21
Codon
Coliform
Collodion
Combination Product
Combinatorial Chemistry
Committee for Medicinal Products for Human Use (CHMP)
Commodity Chemical
Complete Response Letter (CRL)
Compliance
Compliance
Computational Biology
Computational Chemistry
Computer Systems Validation
Consent Decree
Containment Area
Continued Process Verification (CPV)
Continuous Process Verification
Contract Development and Manufacturing Organization (CDMO)
Contract Manufacturing Organization (CMO)
Contract Research and Manufacturing Services (CRAMS)
Contract Research Organization (CRO)
Contract Service Provider
Controlled Release Formula
Conventional Drugs
Conventional Release
Cooperative Research and Development Agreement (CRADA)
Corrective and Preventive Action (CAPA)
Cosmeceutical
COX-2 Inhibitor
CPP
CPV
CQA
CQA
CR
CR&M
CRA
CRADA
CRAMS
Cream
CRF
Critical Micelle Concentration
Critical Process Parameter (CPP)
Critical Quality Attribute (CQA)
Critical Quality Attribute (CQA)
CRL
CRO
Crystallography
CSP
current Good Manufacturing Practices (cGMP)
Customer Relationship Management (CRM)
Cytotoxic

D-value
Data and Safety Monitoring Board (DSMB)
DDS
Delayed Release
Derivatives
Dermal
DGCI
DHL Vaccine
Differential Scanning Calorimetry (DSC)
Disease Pathway
DNA
DNA Array
Dosage Form
Double Blind
Downstream Bioprocessing
Downstream Processing (DSP)
Drug Delivery
Drug Discovery
Drug Master File (DMF)
Drug Product
Drug Substance
Dry Powder Inhaler
DS
DSMB
DSP

E-Pedigree (alt. ePedigree)
ECTD
EDC
EDQM
Effervescent
Efficacy
EFPIA
EHS
Electronic Data Capture (EDC)
Electronic Trial Master File (eTMF)
EMA
Emollient
Emulsion
Enantiomers
Encapsulation
Endotoxin
Endpoint
Engineering Batch
Enteric Coated
Enterprise Resource Planning (ERP)
Environmental Health and Safety (EHS)
Enzyme
Epitope
ERP
Erythropoietin (EPO)
ESCA
Escherichia Coli or E.coli
Ethics Committee
Ethics Review Board
eTMF
European Directorate for the Quality of Medicines & Healthcare (EQDM)
European Medicines Agency (EMA)
European Pharmacopeia (EP)
Excipient
Expression
Extended Release
Extractable
Extrusion

FAB
FACS
Fast Track
FDA
FDAMA
Fed-Batch Fermentation
Field Alert
Fill and Finish
Fluid Bed Coating
Fluid Bed Powder Coating
Fluorescence-Activated Cell Sorter
Food and Drug Administration
Form 483
Form, Fill, Seal
Freeze Dry and/or Freeze Dryer
FTE
Full-Time Equivalent
Functional Genomics

GAMP
Gas Chromatography (GC)
Gastro-Resistant
GCLP
GCP
GDUFA
Gel
Gene
Gene Expression
Gene Therapy
Generic Drug
Generic Drug User Fee Amendments (GDUFA)
Genetic Engineering
Genome
Genomics
Glass Delamination
GLP
Glycosylation
GMP
GMP Facility
Good Automated Manufacturing Practices
Good Clinical Laboratory Practice (GCLP)
Good Clinical Practice (GCP)
Good Laboratory Practice (GLP)
Good Manufacturing Practice (GMP)
Good Tissue Practice (GTP)
Granules
GS Expression System
GTP
Guidance Document
Gum
GxP

Half-Life
Hard-Shell Capsule
HCP
Health Technology Assessment
HEPA
HETP
High Efficiency Particulate Air (HEPA) Filters
High Potency API (HPAPI)
High Pressure Liquid Chromatography (HPLC)
High-Throughput Screening (HTS)
HIPAA
Hit
HME
Host Cell Proteins (HCPs)
Host Range
Host System
Hot Melt Extrusion (HME)
HPAPI
HPLC
HTA
HTS
Humanization
Hybridoma

ICH
IDMC
Ig
Immediate Release (IR)
Immunoglobulin (IgA, IgD, IgE, IgG, and IgM)
Implant
In silico
In vitro
In vivo
In-Licensing
In-process control (IPC)
Inactive Pharmaceutical Ingredient
IND
Independent Data Monitoring Committee (IDMC)
Indian Pharmacopeia (IP)
Individualized Medicine
Infectious Diseases
Informatics
Inhalation (by inhalation)
Inhalation Powder
Injection (by injection)
Insert
Installation Qualification (IQ)
Institutional Review Board (IRB)
Intellectual Property (IP)
Interferons
International Conference on Harmonization (ICH)
International Organization for Standardization (ISO)
Intraocular
Investigational New Drug Application (IND)
Investigator
IQ
IRB
Irrigation

Japanese Pharmacopoeia (JP)
Jelly
Joint Services Document
JPMA
JSD

Key Process Parameter (KPP)
kGy
Kinase
KPP

Lab-on-a-Chip (LOC)
Laboratory Information Management Systems (LIMS)
Large Volume Parenteral (LVP)
LC/GC
LC/MS-MS
Leachables
Lead
Lead Compound
Lead Discovery
Lead Optimization
Legacy Systems
Ligand
LIMS
Limulus Amebocyte Lysate (LAL)
Liposome
Liquid Chromatography/Gas Chromatography (LC/GC)
Liquid Chromatography/Mass Spectrometry (LC/MS)
Lot
Lotion
Lozenge
LVP
Lyophilization
Lyophilizer

MAb
Macromolecules
Marker/ Biomarker
Mass Spectrometer
Master Cell Bank
Master Service Agreement
Material Safety Data Sheet (MSDS)
MBP
Medicinal Chemistry
Medium (pl. Media)
Metabolic Induction
Metabolic Inhibition
Metabolic Transformation
Metered-Dose Inhaler (MDI)
Methicillin Resistant Staphylococcus aureus
Method Qualification
Methods Validation
MHLW
MHRA
Microarray
Microcapsule
Microencapsulation
Microprecipitated Bulk Powder (MBP)
Modified Release
Monoclonal Antibody (MAb)
MRSA
MSA
Multiparticulate
Murine
Mutagenic

Nanotechnology
Nasal
National Drug Code (NDC)
National Formulary
NCE
NDA
Near Infrared Spectroscopy (NIRS)
Neoplastic
New Biologic Entity (NBE)
New Chemical Entity (NCE)
New Drug Application (NDA)
New Molecular Entity (NME)
No Observed Adverse Effect Level (NOAEL)
NOAEL
Non-Research Development Organization (NRDO)
Nuclear Magnetic Resonance (NMR)
Nucleic Acid Hybridization
Nucleic Acids
Nucleotides
Nutraceutical

Occupational Exposure Limit
OEL
Off-Label Use
Ointment
Oligonucleotides
Oncogenic
Operational Qualification (OQ)
Ophthalmic
OQ
Oral Solid Dosage
Orally Disintegrating
Orange Book
Oro-Pharyngeal
Orphan Drugs
OTC
Otic
Out of Specification (OOS)
Out-Licensing
Out-of-Trend (OOT)
Over the Counter (OTC)

PAb
PAI
Parenteral Drug
PAS
Paste
PAT
Patent
PCR
PDE
PDUFA
PEGylation
Pellet
Penem
Penicillin
Peptide
Peptidomimetic
Permissible Exposure Limit (PEL)
Permitted Daily Exposure (PDE)
Personal Protective Equipment (PPE)
Personalized medicine
PET
Pharmacodynamics (PD)
Pharmacoeconomics
Pharmacogenetics
Pharmacogenomics
Pharmacokinetics (PK)
Pharmacology
Pharmacopoeia
Pharmacovigilance
Phase 0
Phase I
Phase II
Phase III
Phase IV
Phenotype
Photo Oxidation
Photooxidation
PhRMA
Pill
Pilot-Plant Scale
PK
Placebo
Plant-Made Pharmaceutical (PMP)
Plasmids
Plate Theory
PMP
Polyclonal Antibody (PAb)
Polymerase Chain Reaction (PCR)
Positron Emission Tomography (PET)
Post-translational Modification
Potent Compound
Powered Air Purifying Respirators (PAPR)
PQ
Pre-Approval Inspection (PAI)
Preclinical studies
Preformulation
Prescription Drug User Fee Act (PDUFA)
Primary Packaging
Prior Approval Supplement
Process Analytical Technologies (PAT)
Process Qualification (PQ)
Process Validation
Prospective Validation
Protein
Proteome
Proteomics
Protocol
Proven Acceptable Range (PAR)

QA
QbD
QC
Qualification batches
Qualified Person (QP)
Quality Agreement
Quality Assurance (QA)
Quality by Design
Quality Control (QC)
Quantitative Whole Body Autoradiography
Quarantine
Question-Based Review (QBR)

Radio Frequency Identification (RFID)
Radiolabeling
Rate Theory
Rational Drug Design
Receptor
Rectal
Reference Listed Drug (RLD)
Registration batches
REMS
Reprocessing
Request For Information (RFI)
Request for Proposal (RFP)
Request for Quotation (RFQ)
Resampling
Responsible Person (RP)
Retesting
RFID
RFP
Risk Evaluation and Mitigation Strategy (REMS)
RNA
RNA interference (RNAi)
RNAi

SafeBridge Certification
SAR
SBA
Scale-Up
Scale-Up and Post-Approval Changes (SUPAC)
Scanning Electron Microscopy (SEM)
Secondary Metabolism
Secondary Metabolites
Secondary Packaging
Self Emulsifying Drug Delivery System (SEDDS)
Semisolid
Serious Adverse Event (SAE)
SFC
Shampoo
Single Nucleotide Polymorphism (SNP)
Single Use Bioreactor (SUB)
Single-Use System (SUS)
Small Molecule Drug
Small Molecule Library
Small Volume Parenteral (SVP)
SMEPAC
sNDA
SNP
Soap
Soft Gel Capsule (also Softgel)
Solid Dosage
Solid Oral Dosage Form
Solution
SOP
Special Protocol Assessment (SPA)
Specialty Pharma
Spheronizer
Spray Dried Dispersion (SDD)
Spray Drying
Stability
Standard Operating Procedures
Standardized Measurement of Particulate Airborne Concentration
Statin
Structural Genomics
Structure-Activity Relationship (SAR)
Structure-Based Drug Design
Structure-Property Relationship (SPR)
Sublingual
Summary Basis of Approval
SUPAC
Supercritical Fluid Chromatography (SFC)
Supplemental New Drug Application (sNDA)
Supply Agreement
Suppository
Suspension
Sustained Delivery
SVP
Synthetic Biology

Tablet
Target Product Profile
Target Validation
Technology Transfer
Temporary Content Title
Temporary Content Title
Temporary Content Title
Terminal Sterilization
TGA
Theranostics
Therapeutics
Topical
TPP
Transcription
Transdermal
Transfection
Transgenic Organism
Transgenics
Translation
Transmissible Spongiform Encephalopathy (TSE)
Troche

Ultra Performance Liquid Chromatography
United States Pharmacopeia (USP)
UPLC
Upstream Bioprocessing
Urethral
USP
USP-NF

Vaccine
Vaginal
Validated Target
Validation
Validation batches
Validation Protocol
Vehicle
Vitamin

Warning Letter
Water For Injection (WFI)
WFI
Working Cell Bank
World Health Organization (WHO)
Wurster Process

X-Ray Crystallography
X-Ray Photoelectron Spectroscopy (XPS)
Xenobiotic
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