510(k) |
Pre-market notification (Medical devices substantially equivalent to products already on the market) |
---|---|
AADA |
Abbreviated Antibiotic Drug Application |
AAFCO |
American Association of Feed Control Officials |
ADE |
Adverse Drug Event |
ADAA |
Animal Drug Availability Act of 1996 |
ADR |
Adverse Drug Report |
ADUFA |
Animal Drug User Fee Act |
AERS |
Adverse Events Reporting System |
AHI |
Animal Health Institute |
AIDS |
Acquired Immune Deficiency Syndrome |
AMDUCA |
Animal Medicinal Drug Use Clarification Act |
ANADA |
Abbreviated New Animal Drug Application |
ANDA |
Abbreviated New Drug Application |
ANPR |
Advanced Notice of Proposed Rulemaking |
ANSI |
American National Standards Institute |
APHIS |
Animal Plant and Health Inspection Service (USDA) |
AR |
Anti-microbial Resistance |
AVMA |
American Veterinary Medical Association |
BIMO |
Bioresearch Monitoring |
BIMS |
Biological Investigational New Drug Application Management System |
BCCP |
Business Continuity and Contingency Plan |
BLA |
Biologics License Application |
BLT |
Blood Logging and Tracking System |
BSE |
Bovine Spongiform Encephalopathy (Mad Cow Disease) |
BSL |
Biosafety Level |
BT |
Bioterrorism |
CABS |
Conformity Assessment Bodies |
CAERS |
CFSAN Adverse Event Reporting System |
CARS |
Compliance Achievement Reporting System |
CBER |
Center for Biologics Evaluation and Research (FDA) |
CDC |
Centers for Disease Control and Prevention |
CDER |
Center for Drug Evaluation and Research (FDA) |
CDRH |
Center for Devices and Radiological Health (FDA) |
CFO |
Chief Financial Officer |
CFSAN |
Center for Food Safety and Applied Nutrition (FDA) |
CGMPs |
Current Good Manufacturing Practices |
CIP |
Critical Infrastructure Protection |
CJD |
Creutzfeldt-Jakob disease |
CMC |
Chemistry, Manufacturing, and Controls |
CWD |
Chronic Wasting Disease |
COMSTAS |
Compliance Status Information System |
COBOL |
Common Business Oriented Language |
COOP |
Continuity of Operations |
CRADA |
Cooperative Research and Development Agreement |
CRO |
Contract Research Organization |
CRS |
Contamination Response System |
CT |
Counter terrorism |
CTS |
Correspondence Tracking System |
CVM |
Center for Veterinary Medicine (FDA) |
CWD |
Chronic Wasting Disease |
DHHS |
Department of Health and Human Services |
DNA |
Deoxyribonucleic Acid |
DOD |
Department of Defense |
DOL |
Department of Labor |
DQRS |
Drug Quality Reporting System |
DRLS |
Drug Registration and Listing System |
DSHEA |
Dietary Supplement Health and Education Act |
EDR |
Electronic Document Room |
EDMS |
Electronic Data Management System |
EIP |
Emerging Infection Program |
EIR |
Establishment Inspection Report |
ELA |
Establishment License Application |
EPA |
Environmental Protection Agency |
ERS |
Economic Research Service |
ETS |
Environmental Tobacco Smoke |
EU |
European Union |
FAA |
Federal Aviation Administration |
FACTS |
Field Accomplishment and Compliance Tracking System |
FAIR Act |
Act Federal Activities Inventory Reform Act |
FAO |
Food and Agricultural Organization (United Nations) |
FAS |
Foreign Agriculture Service (USDA) |
FDA |
Food and Drug Administration |
FDAMA |
Food and Drug Administration Modernization Act of 1997 |
FFD&C Act |
Federal Food, Drug and Cosmetic Act |
FIS |
Field Information System |
FLQ |
Fluoroquinolone |
FMD |
Foot and Mouth Disease |
FMFIA |
Federal Manager’s Financial Integrity Act |
FORCG |
Food Outbreak Response Coordination Group |
FPL |
Final Printed Label |
FPLA |
Fair Packaging and Labeling Act |
FSI |
Food Safety Initiative (National) |
FSIS |
Food Safety Inspection Service (USDA) |
FTC |
Federal Trade Commission |
FTE |
Full-time Equivalent |
FY |
Fiscal Year (October - September) |
GAO |
General Accounting Office |
GAPs |
Good Agricultural Practices |
GATT |
General Agreement on Tariffs and Trade |
GeMCRIS |
Genetic Modification Clinical Research Information System |
GLP |
Good Laboratory Practices |
GMO |
Genetically Modified Organisms |
GMPs |
Good Manufacturing Practices |
GPRA |
Government Performance and Results Act of 1993 |
GRAS |
Generally Recognized as Safe Food Ingredients |
GSFA |
General Standards for Food Additives |
GTIS |
Gene Therapy Information System |
HACCP |
Hazard Analysis Critical Control Points |
HCV |
Hepatitis C Virus |
HDE |
Humanitarian Device Exemption |
HIV |
Human Immunodeficiency Virus |
HUD |
Humanitarian Use Device |
IAG |
Interagency Agreement |
ICAAC |
Interscience Conference on Antimicrobial Agents and Chemotherapy |
ICH |
International Conference on Harmonization |
IDE |
Investigational Device Exemption |
INAD |
Investigational New Animal Drug |
INADA |
Investigational New Animal Drug Application |
IND |
Investigational New Drug |
IOM |
Institute of Medicine |
IRB |
Institutional Review Board |
ISLI |
International Life Sciences Institute |
ISO |
International Standards Organization |
ISRS |
Individual Safety Reports |
IT |
Information Technology |
IVD |
In Vitro Diagnostic |
JECFA |
Joint Expert Committee on Food Additives |
JIFSAN |
Joint Institute for Food Safety and Applied Nutrition |
JINAD |
Generic Investigational New Animal Drug |
LACF |
Low Acid Canned Foods |
LAN |
Local Area Network |
LBITF |
Least Burdensome Industry Task Force |
MALDI |
Matrix Assisted Laser Desorption Ionization |
MAB |
Metastable Atom Bombardment |
MATS |
Management Assignment Tracking System |
MBM |
Meat and Bone Meal |
MDR |
Medical Device Reporting System |
MDUFMA |
Medical Device User Fee and Modernization Act |
MedSun |
Medical Product Surveillance Network |
MERS-TM |
Medical Event Reporting System for Transfusion Medicine |
MFA |
Medicated Feed Application |
MMBM |
Mammalian Meat and Bone Meal |
MOU |
Memorandum of Understanding |
MPRIS |
Mammography Program Reporting and Information Systems |
MQSA |
Mammography Quality Standards Act |
MRA |
Mutual Recognition Agreement |
MUMS |
Minor Use/Minor Species |
NADA |
New Animal Drug Application |
NAFTA |
North American Free Trade Agreement |
NAFTA TWG |
TWG North American Free Trade Agreement Technical Working Group |
NAHMS |
National Animal Health Monitoring System |
NARMS |
National Antimicrobial Resistance Monitoring System |
NAS |
National Academy of Sciences |
NASS |
National Agricultural Statistics Survey |
NAT |
Nucleic Acid Test |
NCCLS |
National Committee on Clinical Laboratory Standards |
NCI |
National Cancer Institute |
NCIE |
Notice of Claimed Investigational Exemptions |
NCTR |
National Center for Toxicological Research (FDA) |
NDA |
New Drug Application |
NDE/MIS |
New Drug Evaluation Management Information System |
NIAID |
National Institute of Allergy and Infectious Diseases |
NIBSC |
National Institute for Biological Standards and Control |
NIDA |
National Institute on Drug Abuse |
NIEHS |
National Institute for Environmental Health Sciences |
NIH |
National Institutes of Health |
NLEA |
Nutrition Labeling and Education Act |
NME |
New Molecular Entity |
NOH |
Notice of Hearing |
NPR |
National Partnership for Reinventing Government |
NPRM |
Notice of Proposed Rulemaking |
NRC |
National Research Council |
NTP |
National Toxicology Program |
nvCJD |
new variant Creutzfeldt-Jakob disease |
NVPO |
National Vaccine Program Office |
OASIS |
Operational and Administrative System for Import Support |
OBRR |
Office of Blood Research and Review (CBER) |
OCTGT |
Office of Cellular, Tissues and Gene Therapies (CBER) |
OPA |
Office of Premarket Approvals (CFSAN) |
ORA |
Office of Regulatory Affairs (FDA) |
ORISE |
Oak Ridge Institute for Science and Education |
OSHA |
Occupational Safety and Health Administration |
OTC |
Over-the-Counter |
OTR |
Office of Testing and Research (CDER) |
OTRR |
Office of Therapeutics Research and Review (CBER) |
OVRR |
Office of Vaccines Research and Review (CBER) |
PAS |
Public Affairs Specialist (FDA) |
PDPs |
Product Development Protocols |
PDUFA |
Prescription Drug User Fee Act of 1992 |
PERV |
Porcine endogenous retrovirus |
PIFSI |
Produce and Food Safety Initiative |
PISI |
Protocol Investigator Site Inspection |
PLA |
Product License Application |
PMA |
Premarket Approval (Application to market medical device that requires Premarket approval) |
PMN |
Premarket Notification |
PODS |
Project-Oriented Data System |
PQRI |
Product Quality Research Initiative |
QSAR |
Quantitative Structure Activity Relationship |
QSIT |
Quality System Inspection Technique |
RA |
Rheumatoid Arthritis |
RCHSA |
Radiation Control for Health and Safety Act |
REGO |
Reinventing Government Initiative |
RIMS |
Regulatory Information Management Staff (CBER) |
RMS-BLA |
Regulatory Management System-Biologics License Application |
RVIS |
Residue Violation Information System |
SAB |
Science Advisory Board |
SAMHSA |
Substance Abuse and Mental Health Services Administration |
SBREFA |
Small Business Regulatory Enforcement Fairness Act |
SE |
Salmonella Enteriditis |
SN/AEMS |
Special Nutritional Adverse Events Monitoring System |
STARS |
Submission Tracking and Review System |
StmDT104 |
Salmonella Tphimurium DT 104 |
TB |
Tuberculosis |
Tof |
Time of flight |
TRIMS |
Tissue Residue Information System |
UK |
United Kingdom |
UMCP |
University of Maryland-College Park |
USDA |
United States Department of Agriculture |
VAERS |
Vaccine Adverse Event Reporting System |
vCJD |
variant Creutzfeldt-Jakob disease |
VEE |
Venezuelean Equine Encephalitis |
VICH |
Veterinary International Cooperation on Harmonization |
VFD |
Veterinary Feed Directive |
VICH |
Veterinary International Conference on Harmonization |
WHO |
United Nations World Health Organization |
WNV |
West Nile Virus |
WTO |
World Trade Organization |