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510(k)Medical Device Premarket Notification
AADAAbbreviated Antibiotic Drug Application
ADMEAbsorption, Distribution, Metabolism, and Excretion
ADRAdverse Drug Reaction
AERSAdverse Event Reporting System (FDA)
ANADAAbbreviated New Animal Drug Application
ANDAAbbreviated New Drug Application
CANDAComputer-Assisted New Drug Application
CAPLAComputer-Assisted Product License Application
CAPLARComputer-Assisted Product License Agreement Review (FDA)
CBERCenter for Biologics Evaluation and Research
CDCCenters for Disease Control and Prevention
CDERCenter for Drug Evaluation and Research
CDRHCenter for Devices and Radiological Health
CFRCode of Federal Regulations
CFSANCenter for Food Safety and Applied Nutrition
CMCChemistry and Manufacturing Controls
CNSCentral Nervous System
CRAClinical Research Associate
CROContract Research Organization
CSAClinical Study Agreement
CSRClinical Study Report
DEADrug Enforcement Administration
DHHSDepartment of Health and Human Services
DIADrug Information Association
DSMBData and Safety Monitoring Board
DSURDevelopment Safety Update Report
EABEthical Advisory Board
EPAEnvironmental Protection Agency
EPLEffective Patent Life
F2FFace-to-Face Meeting
FDAFood and Drug Administration
FDCAFood, Drug, & Cosmetic Act
FTCFederal Trade Commission
GCPGood Clinical Practice
GLPGood Laboratory Practice
GMPGood Manufacturing Practice
GRASGenerally Recognized as Safe (food ingredients)
HDEHumanitarian Device Exemption
IBInvestigator's Brochure
ICHInternational Conference on Harmonization
ICFInformed Consent Form
IDEInvestigational Device Exemption
INDInvestigational New Drug
INDCInvestigational New Drug Committee
IRBInstitutional Review Board
IRCInstitutes Review Committee
ISOInternational Standards Organization
IVDIn Vitro Device, In Vitro Diagnostics
LOALetter of Agreement
MADMultiple Ascending Dose
MDDsMedical Device Directives
MDMAMedical Device Manufacturers Association
MDRMedical Device Reporting
MDVMedical Device Vigilance
NAFNotice of Adverse Findings (FDA Post-audit Letter)
NAINo Action Indicated (favorable FDA post- inspection classification)
NCENew Chemical Entity
NDANew Drug Application
NIAIDNational Institute of Allergies and Infectious Diseases (NIH)
NIHNational Institutes of Health
NINDSNational Institute of Neurological Disorders & Stroke (NIH)
NMENew Molecular Entity
NMINon-medicinal Ingredients
PDMAPrescription Drug Marketing Act
PDPProduct Development Protocols (for medical devices)
PDRPhysician's Desk Reference
PDUFAPrescription Drug User Fee Act
PHRMAPharmaceutical Research and Manufacturers Association
PHSPublic Health Service
PI Package Inserts
PI Principal Investigator
PLAProduct License Application (for biologics)
PMAPre-Market Approval (application) (for medical devices)
PMSPostmarketing Surveillance
QAQuality Assurance
QCQuality Control
QOLQuality of Life
QSITQuality Systems Inspections Technique
RADARRisk Assessment of Drugs- Analysis and Response
RFIRequest for Information
SAESerious Adverse Event
SADSingle Ascending Dose
SNDASupplemental New Drug Application
SOPStandard Operating Procedure
TINDTreatment IND
USPUnited States Pharmacopoeia
WLWarning Letter (most serious of post-FDA audit letter, demands immediate action within 15 days)