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