510(k) – 510(k) premarket notification
ACE – Angiotensin-converting enzyme
AEMS – Adverse Event Monitoring System
ARB – Angiotensin receptor blocker
BLA – Biologics License Application
CBER – Center for Biologics Evaluation and Research
CDER – Center for Drug Evaluation and Research
CDRH – Center for Devices and Radiological Health
CMS – Center for Medicare and Medicaid Services
DSC – Drug Safety Communication
EHR- Electronic health records
EMR – Electronic medical records
ESA – Erythropoietin stimulating agent
GBCA – Gadolinium-based contrast agent
GLP-1 RA – Glucagon-like peptide-1 receptor agonists
HCTZ – Hydrochlorothiazide
HDE – Humanitarian device exemption
IAA – Inter-Agency Agreement
IDE – Investigational Device Exemption
MACE – Major adverse cardiac event
NDA – New Drug Application
OSE – Office of Surveillance and Epidemiology
OUS – Outside the U.S.
PLLR – Pregnancy and Lactation Labeling Rule
PMA – Premarket approval application
PPI – Proton pump inhibitor
REMS – Risk Evaluation and Mitigation Strategy
RWD – Real-World Data
RWE – Real-World Evidence
SEE – Substantial Evidence of Effectiveness
U.S. – United States
VHA – Veterans Health Administration
VTE – Venous thromboembolism
