Acronyms
AAPS American Association of Pharmaceutical Scientists
ACC American College of Cardiology
ACE inhibitor angiotensin-converting enzyme inhibitor
ACR American College of Radiology
ACS acute coronary syndrome
ACT-UP AIDS Coalition to Unleash Power
AERS Adverse Event Reporting System
AHA American Heart Association
AIDS acquired immune deficiency syndrome
BQRT biomarker qualification review team
C-Path Critical Path Institute
CAD coronary artery disease
CAST Cardiac Arrhythmia Suppression Trial
CBER Center for Biologics Evaluation and Research
CD4 cells CD4+ T-lymphocytes
CDC Centers for Disease Control and Prevention
CDER Center for Drug Evaluation and Research
CDRH Center for Devices and Radiological Health
CETP cholesteryl ester transfer protein
C.F.R. Code of Federal Regulations
CFSAN Center for Food Safety and Applied Nutrition
CHD coronary heart disease
CHF congestive heart failure
CIN cervical intraepithelial neoplasia
CLIA Clinical Laboratory Improvement Amendments
CMOD International Partnership for Critical Markers of Disease
CMS Centers for Medicare & Medicaid Services
CPI Critical Path Initiative
CRP C-reactive protein
CRT cardiac resynchronization therapy
CSCR Cardiac Safety Research Consortium
CSPI Center for Science in the Public Interest
CT computed tomography
cTn cardiac troponin
CVD cardiovascular disease
DHA docosahexaenoic acid
DIA Drug Information Association
DRV daily recommended value
DSHEA Dietary Supplement Health and Education Act
DTC direct-to-consumer
EMEA European Medicines Agency
EPA eicosapentaenoic acid
FAERS FDA Adverse Event Reporting System
FDA Food and Drug Administration
FDAAA Food and Drug Administration Amendments Act
FDAMA FDA Modernization Act
FDCA Food, Drug, and Cosmetic Act
FDG-PET [18F]-2-fluoro-2-deoxy-D-glucose positron emission tomography
FNIH Foundation for the National Institutes of Health
FOP front of packaging
FR Federal Register
FY fiscal year
GAO Government Accountability Office
GIST gastrointestinal stromal tumor
GTV gross tumor volume
HDL high-density lipoprotein
HDL-C high-density lipoprotein cholesterol
HHS Department of Health and Human Services
HIV human immunodeficiency virus
HIV-1 RNA HIV-1 (strain of HIV) ribonucleic acid
HMG CoA 3-hydroxy-3-methylglutaryl-coenzyme A
HPV human papillomavirus
HRT hormone replacement therapy
Hs-CRP high-sensitivity C-reactive protein
ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
IFICF International Food Information Council Foundation
IFT Institute of Food Technologists
IOM Institute of Medicine
IPRG Interdisciplinary Pharmacogenomics Review Group
iSAEC International Serious Adverse Events Consortium
ISPY-2 Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis
IT infomation technology
LDL low-density lipoprotein
LDL-C low-density lipoprotein cholesterol
LDL-P low-density lipoprotein particle number
LPS lipopolysaccharide
LVH left ventricular hypertrophy
MI myocardial infarction
MRI magnetic resonance imaging
MTHFR 5,10 methylenetetrahydrofolate reductase
NACB National Academy of Clinical Biochemistry
NCCTG North Central Cancer Treatment Group
NCEP National Cholesterol Education Program
NCFST National Center for Food Science and Technology
NCI National Cancer Institute
NDA New Drug Application
NHLBI National Heart, Lung, and Blood Institute
NIH National Institutes of Health
NLEA Nutrition, Labeling, and Education Act
NLM National Library of Medicine
NSABP National Surgical Adjuvant Breast and Bowel Project
NSCLC non-small-cell lung cancer
OBQI Oncology Biomarker Quality Iniative
OMOP Observational Medical Outcomes Partnership
OSE Office of Surveillance and Epidemiology (FDA)
PDUFA Prescription Drug User Fee Act
PET positron emission tomography
PhRMA Pharmaceutical Research and Manufacturers of America
PPAR peroxisome proliferator–activated receptor
PSA prostate-specific antigen
PSTC Predictive Safety Testing Consortium
RACC reference amount customarily consumed
RCT randomized controlled trial or reverse cholesterol transport
RDI Reference Daily Intake
REMS risk evaluation and mitigation strategies
RiskMAPS risk minimization action plans
RNA ribonucleic acid
SSA significant scientific agreement
TMUGS tumor marker utility grading system
US ultrasound
USDA U.S. Department of Agriculture
VLDL very low-density lipoprotein
VXDS voluntary exploratory data submission
WHO World Health Organization