Acronym
3011 form
510(k)
AADA
AAS
ABE
ABG
ACE
ACT
ACTH
ad lib
ADaM
ADE
ADE
ADH
ADI
ADME
ADR
ADR
AE
AER
AERS
AF
AFAB
AFP
AHF
AHU
AIDS
aka
ALARA
ALL
AMA
AME
AML
ANA
ANCOVA
AND
ANDA
ANDS
ANSI
AODM
API
AQL
AR
ARDS
ARF
AS
ASAP
ASCII
ASCVD
ASD
ASHD
ASR
AUC
AV
A-V
A-VO2
BA/BE
BBB
BBR
BCAA
BE
BEq
BGH
BiB
BID
BIVAS
BLA
BMI
BMR
BMT
BP
BPD
BPD
BPH
BPM
BRBs
BSA
BSE
Bt
BUN
BW
C of A
CA
CA
CAs
CABE
CABG
CAD
CALA
CAP
CAP
CAPA
CAPD
CAPLAR
CARS
CAS
CAT
CBC
CBE
CBER
CBG
CBSC
CCC
CCU
CCU
CD
CD
CDA
CDASH
CDC
CDER
CDISC
CDM
CDR
CDRH
CD-ROM
CE Mark
CEN
CERB
CF
CFC
CFR
CFSAN
CFU
CGL
cGMP
CGMPR
CGTP
CHF
ChLIA
CHMP
CHO
CI
CIB
CIO
CIOMS
CJD
Clarifax
CM
CMC
CMC
CMV
CNS
COA
COLD
COPD
CoS
COSTART
CP
CP
CPAP
CPID
CPK
CPMP
CPR
CRA
CRADA
CRCL
CRF
CRF
CRIX
CRO
CRO
CRP
CRT
CRTP
CS
CSA
CSBE
CSF
CSI
CSO
CSR
CSV
CT
CTA
CTA
CTA-A
CTC
CTC
CTD
CTM
CTO
CTS
CTX
CV
CVA
CVA
CVM
CVMP
CVP
CY
D&C
DAL
DARRTS
DAT
DB
DBMS
DC
DC
DES
DHF
DHHS
DHR
DI
DIC
DINA
DJD
DKA
dL
DLI
DM
DMF
DMR
DMSO
DNA
DNR
DOA
DOE
DP
DPI
DPL
DPT
DRF
DRI
DRV
DSC
DT
DTaP
DTD
DTR
DV
DVD
DVT
DX
EA
EAA
EC
eCDT
ECG
ECL
ECMO
e-CRF
ECT
eCTA
eCTA-A
ED
EDI
EDMF
EDMS
EDSR
EEG
EFPIA
EHR
EI
EI
EIA
eIND
EIR
EKG
ELA
ELIPS
ELISA
ELPS
ELR
ELS
EMC
EMEA
EMI
EMS
EMV
ENL
ENT
EOM
EOP1
EOP2
EOS
EP
EPA
EPI
EPLC7
ERB
ERCP
ERS
ERSR
ERT
ES
ESG
ESIG
ESR
ESTRI
ET
EtOH
ETT
EU
EUA
EVS
EWG
FACTS@FDA
FAQ
FASTAR
FAX
FBS
FD&C ACT
FDA
FDAMA
FDC
FDCA
FFD & C
FFP
FHA
FLQ
FMAMA
FMD
FMEA
FMECA
FNH
FOB
Fr.P.
FRC
FTA
FTE
FTIM
FTT
FUO
FVC
Fx
FYI
GAT
GC
GEP
GGP
GHTF
GM
GRAS/E
GSP
gt
GTT
gtt
GU
GXT
H/H
H/H
HA
HAA
HAART
HAD
HAM/TSP
HAV
HBOC
HBP
HBV
HCG
HCT
HCT/P
HCV
HDC
HDL
HDPE
HEENT
HF
Hgb
HGH
HHS
HIPAA
HIV
HL7
HLBT
HNK cells
HPC
HPC
HPK
HPV
HR
HS
HSBT
HSV
HTLV
HTLV-III
HTN
HVAC
I&D
I&O
IBE
ICD
ICD-9-CM
ICH
ICL
ICSR
ICU
ID
IDDM
IDE
IEC
IEE
IEF
IFA
IG
IGF
IGIV
IM
IMPD
IND
IND
INDA
INDC
INN
INN
IP
IPV
IQ
IRB
IRB
IRDM
ISE
ISO
ISR
ISS
ISS/ISE
IT
ITT
IUO
IUPAC
IV
IVC
IVC
IVD
IVF
IVIG
IVMD
IVP
JP
JPMA
kcal
Kg
LAp and Lam
LASER
LCMS
LD
LD50
LDPE
LIMS
LMS
LOCF
LOD
LOINC
LOQ
LOV
LRIS
LS/LS
LVP
M2
M4
MA
MAA
mAb
MAD
MAH
MAPP
MAS cell
MAT
MAV
MBC
MDD
MDR
MDUFMA
MedDRA
MEDWATCH
MEG
MF
MHRA
MHW
MI
MIS
MLD
MMR
MOA
MRA
MRA
MRA
MRD
MRI
MRP
MRS
MSDS
MSI
MTBF
MTD
n.b.
NADA
NAF
NAI
NAS
NAT
NC
NC
NCE
NCI
NCP
NCPDP
NCS
NDA
NDC
NDE
NDS
NDS
NHP
NIH
NLM
NLT
NME
NMR
NMT
NOAEL
NOC
NOC/c
NOD
NOEL
NON
NON-W
NS
NSAID
NSE
NSR
NTA
nvCJD
OB-GYN
OC
OCIO
ODM
OEM
OLE
OMB
OMT
OOS
OPL
OPV
OQ
ORA
Orange Book
OSHA
OT
OTC
OTC
PAC
PAGE
PAI
PAR
PAS
PBPC
PBSC
PCB
PCP
PCR
PCT
PCT
PD
PDE
PDF
PDR
PDUFA
PE
PERT
PERV
PET
PET
PETG
PI
PI
PK
PKA
PKI
PKLN
PLA
PLI
PLR
PM
PMA
PMA
PMA
PMAA
PMC
PMF
PMO
PMOA
PMS
PO
ppb
PPI
ppm
PPT
PQ
PQ
PR
PRN
PrP
PS
PST
PSUR
PTFE
PTO
PTR
PUD
PV
PVC
Q&A
QA
QC
QD
QID
QMS
QOD
QoL
QOS
QP
QSIT
QU
R&D
RAD
RADAR
RADAR
RBC
RCH
RCT
RDBMS
RDI
RDT
RFID
RIBA™
RIM
RIPA
RLD
RMS
RNA
ROI
RPMD
RPS
RR
RR
RSS
RSS
RSS
RSV
RSVIG
RSVIGIV
RTA
RTF
RTF
Rx
S/NDS
SAD
SADR
SAE
SANDS
SARS
SAS
SBA
SC
SC
SCL
SD
SDLC
SDM
SDN
SDO
SDS
SDTM
SEND
SFB
SIA
SIDS
SIP
siRNA
SIT
SMART
SME
SMF
SMO
SMTP
sNDA
SNDS
SNRI
SOC
SOP
SOPP
SOW
SPC
SPECT
SPL
SPOTS
SQ
SQL
SQT
SR
SRD
SRF
SSE
SSRI
STARS
STCD
STF
STN
SUD
SUPAC
SUPAC-IR
SVP
T/PT
TAA
TAH
TAVC
TB
TBD
TBP
TCP/IP
TDI
TEP
TI
TID
TIFF
TIND
TK
TMJ
TMO
TNTC
TOC
TOL
TPD
TPN
TQM
TRALI
TSE
TSH
TSS
TVC
U
UA
UCB
UCBU
UDF
UDI
UIN
UK
ULN
ULPA
UNII
URL
URS
USAN
USC
USP
USPC
USP-DI
USP-NF
USPTO
UV
V/V
VAERS
VBPF
vCJD
VCS
VE
VEE
VIG
VMF
VMP
W3C
WBC
WebSDM
WHO
WIB
WL
WNME
WNV
WSHSC
WWW
WYSIWYG
XDR-TB
XML
YTD
Definition
Drug Submission Application Form
section of the Food, Drug, and Cosmetic Act that deals with premarket notification
abbreviated antibiotic drug application
acute abdominal series
adverse biologic experience
arterial blood gas
adverse clinical event
applied clinical trials
adrenocorticotropic hormone
as much as needed
analysis dataset model (CDISC)
adverse drug event
adverse drug experience
antidiuretic hormone
acceptable daily intake
absorption, distribution, metabolism and excretion
adverse drug report
adverse drug reaction
adverse event
adverse event report
Adverse Event Reporting System
atrial fibrillation
absorbable fibrin adhesive bandage
alpha-fetoprotein
antihemophilic factor
air handling unit
acquired immune deficiency syndrome
also known as
as low as reasonably achievable
acute lymphocytic leukemia
American Medical Association
absorption, metabolism, excretion
acute myelogenous leukemia
antinuclear antibody
analysis of covariance
abbreviated new drug application number (ORA AofC code)
abbreviated new drug application
Abbreviated New Drug Submission
American National Standards Institute
adult onset diabetes mellitus
active pharmaceutical ingredient
acceptable quality level
approvable letter
acute respiratory distress syndrome
acute renal failure
aortic stenosis
as soon as possible
American Standard Code for Information Interchange (computer files)
atherosclerotic cardiovascular disease
atrial septal defect
atherosclerotic heart disease
analyte specific reagent
area under the curve
atrioventricular
arteriovenous
arteriovenous oxygen
bioavailability/bioequivalence
bundle branch block
Bureau of Biologics and Radiopharmaceuticals (Canada)
branched-chain amino acids
Bioequivalence
bioequivalence
bovine growth hormone
Bioinformatics Board
two times per day
Body Image Visual Analog Scale
biologics license application (CBER)
body mass index
basal metabolic rate
Business Modernization / Transformation
blood pressure
biological product deviation
broncho-pulmonary dysplasia
benign prostatic hyperplasia
beats per minute
Business Review Boards
body surface area
bovine spongiform encephalopathy (mad cow disease)
Bacillus thuringiensis
blood urea nitrogen
Body Weight
certificate of analysis
Chemical Abstracts
competent authority (U.K.)
competent authorities
corrective action(s) being effected
coronary artery bypass graft
coronary artery disease
computer-assisted license application
corrective action plan
College of American Pathologists
corrective and preventive action
continuous ambulatory peritoneal dialysis
Computer-Assisted Product License Application Review
Compliance Achievement Reporting System
Chemical Abstracts Service
computerized axial tomography
complete blood count
changes being effected
Center for Biologics Evaluation and Research (FDA)
capillary blood gas
cord blood stem cells
Compliance Coordinating Committee (CDER)
clean catch urine
cardiac care unit
Circular Dichroism
Capillary Electrophoresis
clinical document architecture
Clinical Data Acquisition Standards Harmonization
Center for Disease Control
Center for Drug Evaluation and Research (FDA)
Clinical Data Interchange Standards Consortium
clinical data management
clinical drug request
Center for Devices and Radiological Health (FDA)
compact disc read-only memory
CE (Conformite Europeene or European Conformity) marking
Comite Europeen de Normalisation (European Committee for Standardization)
Centre for the Evaluation of Radiopharmaceuticals and Biotherapeutics
cystic fibrosis
chlorofluorohydrocarbons
Code of Federal Regulations
Center for Food Safety and Applied Nutrition (FDA)
colony forming unit
chronic granulocytic leukemia
current good manufacturing practice
Current Good Manufacturing Practices Regulations
current good tissue practice
congestive heart failure
chemi-luminescent immunoassay
Committee for Medicinal Products for Human Use
carbohydrate
clinical investigator
clinical investigator's brochure
Chief Information Officer
Council for International Organizations of Medical Sciences (WHO)
Creutzfeldt Jakob disease
A fax requesting clarification
configuration management
chemistry, manufacturing and control
Chemistry, Manufacturing and Control
cytomegalovirus
central nervous system
certificate of analysis
chronic obstructive lung disease
chronic obstructive pulmonary disease
certificate of suitability
Coding Symbols for Thesaurus of Adverse Reaction Terms
cerebral palsy
chest pain
continuous positive airway pressure
Certified Product Information Document
creatinine phosphokinase
Committee for Proprietary Medicinal Products (EMEA)
cardiopulmonary resuscitation
clinical research associate
Cooperative Research and Development Agreement
creatinine clearance
case report form
chronic renal failure
Clinical Research Information Exchange (FDA and NCI)
contract research organization
clinical research organization
C-reactive protein
case report tabulations
Clinical Research Training Program
clinically significant
clinical study agreement
Comprehensive Summary Bioequivalence
cerebrospinal fluid
consumer safety inspector
consumer safety officer
Clinical Study Report
comma separated value (file format)
clinical trial
clinical trial application
clinical trial agreement
Clinical Trial Application Amendment
clinical trial certificate
common toxicity criteria
common technical document
clinical trials materials
clinical trial outline
Correspondence Tracking System
clinical trials exemption (UK)
curriculum vitae
costovertebral angle
cerebrovascular accident
Center for Veterinary Medicine (FDA)
Committee on Veterinary Medical Products (EMEA)
central venous pressure
calendar year
dilation and curettage
defect action level
Document Archiving, Reporting and Regulatory Tracking System
diet as tolerated
double-blind
database management system
discontinue
discharge
Drug eluting stent
design history file
Department of Health and Human Services (U.S.)
device history record
diabetes insipidus
disseminated intravascular coagulation
Drug Identification Number Application
degenerative joint disease
diabetic ketoacidosis
deciliter
donor lymphocyte infusion
diabetes mellitus
drug master file
device master record
dimethylsulfoxide
deoxyribonucleic acid
do not resuscitate
dead on arrival
dyspnea on exertion
drug product
dry powder inhaler
Drug Product Licensing (Canada)
diphtheria, pertussis and tetanus
dose range findings (study)
daily reference intake
daily reference value
Data Standards Council
Developmental Test
diphtheria, tetanus and pertussis [vaccine]
document type definition (for electronic interchange)
deep tendon reflexes
daily value
digital video disc
deep venous thrombosis
diagnosis
Enterprise Architecture
essential amino acids
European Community
Electronic Common Technical Document (ICH M2 [Multi-disciplinary Group 2] EWG [Expert Working Group])
electrocardiogram
electrochemiluminescence
extra-corporeal membrane oxygenation
electronic Case Report Form
electroconvulsive therapy
eCTD-formatted Clinical Trial Application
eCTD-formatted Clinical Trial Application Amendment
effective dose
electronic data exchange
European drug master file
Electronic Document Management System
Electronic Document Submission and Review
electroencephalogram
European Federation of Pharmaceutical Industries and Associations
electronic health record
establishent inspection
Establishment Inventory (ORA)
enzyme immunoassay
electronic investigational new drug application
establishment inspection report
electrocardiogram
establishment license application
Electronic Labeling Information Processing System (FDA)
Enzyme-linked immunosorbent assay
establishment licensing and product surveillance
Electronic Labeling Rule
Establishment License Supplement
electromagnetic compatibility
European Medicines Agency (formerly European Medicines Evaluation Agency)
electromagnetic interference
Emergency Medical Services
eye-motor-verbal (Glasgow coma scale)
erythema nodosum leprosum
ear, nose and throat
extraocular muscles
end-of phase 1
end-of-phase 2
end of study
European Pharmacopoeia
Environmental Protection Agency (U.S.)
essential prescribing information
Enterprise Performance Life Cycle
Ethics Review Board
endoscopic retrograde cholangio-pancreatography
electronic regulatory submission
Electronic Regulatory Submissions and Review
Emergency Response Team
effect size
Electronic Submissions Gateway
electronic signature
erythrocyte sedimentation rate
Electronic Standards for the Transfer of Regulatory Information
endotracheal
ethanol
endotracheal tube
European Union
examination under anesthesia
Enterprise Vocabulary Services
expert working group
system for electronically communicating approved drug labeling and for disseminating prescribing information
frequently asked questions
FDA Advanced Submission Tracking and Review Framework
facsimile
fasting blood sugar
Federal Food, Drug, and Cosmetic Act of 1938
Food and Drug Administration
Food and Drug Administration Modernization Act of 1997
Food, Drug, & Cosmetic
Federal Food, Drug, and Cosmetic Act of 1938
Federal Food, Drug and Cosmetic Act of 1938
fresh frozen plasma
Federal Health Architecture
fluoroquinolone
FDA Modernization Act
foot and mouth disease
failure modes and effect analysis
failure modes effects and criticality analysis
febrile non-hemolytic reaction
Follow-on Biologic
Pharmacopee Francaise (French Pharmacopoeia)
functional residual capacity
fault tree analysis
Full Time Equivalent
first time in man
failure to thrive
fever of unknown origin
forced vital capacity
fracture
for your information
genome amplification testing
gonorrhea
good engineering practice
Good Guidance Practice
Global Harmonization Task Force
genetically modified
generally recognized as safe and effective
Good Statistics Practice
drops
glucose tolerance test
drops
genitourinary
graded exercise tolerance (Stress test)
Henderson-Hasselbach equation
hemoglobin/hematocrit
headache
hepatitis-associated antigen
Highly Active Antiretroviral Therapy – the name commonly given to combinations of anti-HIV drugs
Hospital Anxiety and Depression [scale]
HTLV-I-associated myelopathy / tropical spastic paraparesis
hepatitis A virus
hemoblogin-based oxygen carrier
high blood pressure
hepatitis B virus
human chorionic gonadotropin
hematocrit
human cellular and tissue-based products
hepatitis C virus
High dose chemotherapy
high density lipoprotein
high density polyethylene
head, eyes, ears, nose, throat
high frequency
hemoglobin
human growth hormone
Health and Human Services (U.S. Department of)
Health Insurance Portability and Accountability Act of 1996
human immunodeficiency virus
Health Level Seven
heat labile bacterial toxins
human neonatal kidney cells
hematopoietic progenitor cells
human progenitor cells
human pharmacokinetic
human papillomavirus
heart rate
at bedtime
heat stable bacterial toxins
herpes simplex virus
human T-lymphotropic virus
human lymphotropic virus, type III (AIDS agent, HIV)
hypertension
heating, ventilating, and air conditioning
incision and drainage
intake and output
individual bioequivalence
informed consent document
International Classification of Diseases, Ninth Revision, Clinical Modification
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for
Human Use
idiopathic CD4+ T-lymphocytopenia
Individual Case Safety Reports
intensive care unit
Identification
insulin dependent diabetes mellitus
investigational device exemption number (ORA AofC code)
Independent Ethics Committee (DHHS)
intervention effect estimate
Isolectric Focusing
indirect fluorescent antibody
immunoglobulin
insulin-like growth factor
immune globulin intravenous
Information Management
Investigational Medicinal Product Dossier (EU)
investigational new drug
investigational new drug number (ORA AofC code)
investigational new drug application
Investigational New Drug Committee
international nonproprietary name
International Approved Names for Pharmacopoeial Substances
internet protocol
inactivated poliovirus vaccine
installation qualification
Institutional Review Board
Investigational Review Board
insulin resistant diabetes mellitus
integrated summary of efficiency
International Organization for Standardization
Individual Safety Report
Integrated Summary of Safety
integrated summary of safety and effectiveness
information technology
intent to treat
investigation use only
International Union of Pure and Applied Chemistry
intravenous
intravenous cholangiogram
inferior vena cava
in vitro diagnostics
in vitro fertilization
intravenous immunoglobulin
in vitro medical device
intravenous pyelogram
Japanese Pharmacopoeia
Japan Pharmaceutical Manufacturers Association
kilocalories
kilogram
Licence Application and Licence Amendment
light amplification by stimulated emission of radiation
Liquid Chomatography/Mass Spectrometry
lethal dose
lethal dose where 50% of the animal population die
low-density polyethylene
Laboratory Information Management System
Laboratory Management System
last observation carried forward
limit of detection
Logical Observation Identifier Name Codes (Regenstrief Institute)
limit of quantification
list of values (EASE)
Lot Release Imaging System
life supporting/life sustaining
Large-Volume Parenteral – an injection product having a solution volume which exceeds 100 mL
ICH M2 Expert Working Group (EWG) [electronic standards for transmission of regulatory information]
ICH M4 Expert Working Group (EWG) [focusing on Common Technical Documents for sections of the NDA]
Marketing Authorisation
Marketing Authorisation Application
monoclonal antibody
multiple ascending dose
Marketing Authorisation Holder (EC)
Manual of Policy and Procedures
manipulated autologous structural cell
modular antigen transporter
maximum allowable variation
minimum bactericidal concentration
maximum daily dose
medical device reporting
Medical Device User Fee and Modernization Act of 2002
Medical Dictionary for Regulatory Activities
FDA Safety Information and Adverse Event Reporting Program
magnetoencephalography
master file
Medicines and Healthcare products Regulatory Agency (UK)
Ministry of Health and Welfare (Japan's equivalent to the FDA)
myocardial infarction
Management Information System
minimum lethal dose
measles, mumps and rubella
mode of action
magnetic resonance angiography
medical research associate
mutual recognition agreement
multiple rising dose
magnetic resonance imaging
manufacturing resource planning
magnetic resonance spectroscopy
Material Safety Data Sheets
magnetic source imaging
mean time between failures
maximum tolerated dose
note well (nota bene)
new animal drug application
notice of adverse findings
no action indicated
new active substance
nucleic acid-based tests
non-clinical (phase, studies)
Notifiable Change
new chemical entity
National Cancer Institute (NIH)
nonconforming product
National Council for Prescription Drug Programs
not clinically significant
new drug application
National Drug Code (FDA)
new drug evaluation
New Drug Submission (Canada)
new drug study
Natural Health Product
National Institutes of Health (DHHS)
National Library of Medicine (NIH)
not less than
new molecular entity
nuclear magnetic resonance spectroscopy
not more than
no observable adverse effect level
Notice of Compliance
Notice of Compliance with conditions
Notice of Deficiency
no observed effect level
Notice of Non-compliance
Notice of Non-compliance-Withdrawal
Not significant
nonsteroidal anti-inflammatory drug
not substantially equivalent
nonsignificant risk
notice to applicants (EC)
new variant Creutzfeldt-Jakob Disease
obstetrics-gynecology
Office of the Commissioner
Office of the Chief Information Officer
operational data model (CDISC)
original equipment manufacturer
object linking and embedding (Microsoft)
Office of Management and Budget
oral mucosal transudate
out of specification
Office of Planning
oral polio vaccine
operational qualification
Office of Regulatory Affairs
Approved Drug Products with Therapeutic Equivalence Evaluations
Occupational Safety and Health Administration (U.S. Department of Labor)
Operational Test
over-the-counter
ornithine transcarbamylase deficiency
post-approval changes
polyacrylimide gel electrophoresis
pre-approval inspection
proven acceptable range
prior approval supplement
peripheral blood progenitor cell
peripheral blood stem cell
placental cord blood
Pneumocystis carinii pneumonia
polymerase chain reaction
practical clinical trial
photochemical treatment
pharmacodynamics
permitted daily exposure
portable document format
product defect reporting
Prescription Drug User Fee Act of 1992
pharmacoeconomics
product-enhanced reverse transcriptase
porcine endogenous retrovirus
positron emission tomography
polyethylene terephthalate
polyethylene terephthalate G
package insert (approved product labeling)
principal investigator
pharmacokinetics
prekallikrein activator
public key infrastructure
Parklawn Building
product license application (CBER)
pre-license inspection (CBER)
Physicians Labeling Rule
Product Monograph
Pharmaceutical Manufacturer's Association
premarket approval
premarket application
premarket approval application
postmarketing commitment
public master file
Project Medical Officer
primary mode of action
postmarketing surveillance
per os (by mouth)
parts per billion
patient package insert
parts per million
plasma preparation tube
performance qualification
process qualification
pulse rate
as needed
prion protein
particle size
porcine somatotropin
Periodic Safety Update Reports
polytetrafluroethylene
Patent and Trademark Office (U.S. Department of Commerce)
platelet transfusion reaction
peptic ulcer disease
process validation
polyvinyl chloride
questions and answers
quality assurance
quality control
once daily
four times a day
Quality Management System
every other day
quality of life
quality overall summary (of CTD)
qualified person (EU)
quality system inspection technique (CDRH)
quality unit
research and development
Regulatory Affairs Division
risk assessment of drugs - analysis and response
radio detecting and ranging
Red blood cells
remove clinical hold
randomized clinical trial
Relational Database Management System
reference daily intake
rising dose tolerance
radio-frequency identification
recombinant immunoblot assay (Chiron ®)
reference information model (HL7)
radioimunoprecipitation assay
reference listed drug
Reference Member State (Europe)
ribonucleic acid
report of investigation
Regulatory Project Management Division
Regulatory Product Submission
relative risk
repeatedly reactive
really simple syndication
RDF (resource data framework) site summary
rich site summary
respiratory syncytial virus
respiratory synctial virus immune globulin
respiratory synctial virus immune globulin intravenous
refusal-to-accept
refusal to file
rich text format
prescription
supplemental new drug submission (Canada)
single ascending dose
suspected adverse drug reaction
serious adverse event
Supplement to a Abbreviated New Drug Submission
severe acute respiratory syndrome
Symptom Assessment Scale
summary basis of approval
study coordinator
subcutaneous
Symptom Checklist
Standard Deviation
System Development Lifecycle
Submission Data Model (CDISC)
Screening Deficiency Notice
Standards Development Organization
Submission Data Standards (CDISC)
Study Data Tabulation Model (CDISC)
Standard for Exchange of Nonclinical Data
spore-forming bacteria
strip immunoblot assay
sudden infant death syndrome
sterilization in place
small (or short) interfering Ribonucleic Acid
System Integration Test
Submission Management and Review Tracking
significant medical event
site master file
site management organization
simple mail transfer protocol
supplemental new drug application
Supplement to a New Drug Submission
serotonin-norepinephrine reuptake inhibitor
System Organ Class
standard operating procedure
Standard Operating Procedures and Policies
statement of work
Summary of Product Characteristics (EMEA)
single-photon emission computed tomography
structured product labeling
Special Products On-Line Tracking System (CDER)
subcutaneous
structured query language
System Qualification Tests
significant risk
single rising dose
Site Reference File
Summary of Safety and Effectiveness
selective serotonin reuptake inhibitor
Submission Tracking and Reporting System
sterile connecting device
Study Tagging File
submission tracking number
sudden unexpected death
scale up and post-approval changes
scale-up and post-approval changes--immediate release
small-volume parenteral
traceability/product tracing
transfusion-associated AIDS
transfusion-associated hepatitis
total aerobic viable count
tuberculosis
to be determined
therapeutic biologic product
transmission control protocol/internet protocol
tolerable daily intake
therapeutic exchange plasmapheresis
tolerable intake
three times a day
tagged image file format
treatment investigational new drug
toxicokinetics
temporomandibular joint
trial management organization
too numerous to count
total organic carbon
total organic carbon
Therapeutic Products Directorate (Canada)
total parenteral nutrition
Total Quality Management
transfusion-related acute lung injury
transmissible spongiform encephalopathies
thyroid stimulating hormone
Transfusion Safety Study
total viable count
units
urinalysis
umbilical cord blood
umbilical cord blood unit
Universal Disk Format
unique device identification
unique identification number
United Kingdom
upper limit of normal
ultra-low penetration air
Unique Ingredient Identifiers
uniform resource locator
user requirement specification
United States Adopted Name
United States Code
U.S. Pharmacopeia
U.S. Pharmacopeial Convention
United States Pharmacopeia-Drug Information
United States Pharmacopeia-National Formulary
United States Patent and Trademark Office (U.S. Department of Commerce)
Ultraviolet Spectroscopy
verification/validation
Vaccine Adverse Event Reporting System
vegetative bacteria, protozoa and viruses
variant Creutzfeldt Jakob disease
Voluntary Consensus Standard
vaccine efficacy
Venezuelan equine encephalomyelitis
vaccinia immune globulin
veterinary master file
validation master plan
World Wide Web Consortium
white blood cell
Web-based Submission Data Manager
World Health Organisation
Western immunoblot
warning letter
West Nile meningoencephalitis
West Nile virus
water soluble, heat stable chemicals
world wide web
what you see is what you get
extensively drug-resistant tuberculosis
extensible markup language
year to date
Group])
]
e NDA]