A5055038966- Pharmacovigilance and Adverse Drug Reactions
- SARS-CoV-2 and COVID-19 Research
- Viral Infections and Immunology Research
- Clinical Reasoning and Diagnostic Skills
- Heparin-Induced Thrombocytopenia and Thrombosis
- Intramuscular injections and effects
- Bacillus and Francisella bacterial research
- Biosimilars and Bioanalytical Methods
- Primary Care and Health Outcomes
- Electronic Health Records Systems
- Ethics in Clinical Research
- Statistical Methods in Clinical Trials
- Infective Endocarditis Diagnosis and Management
Center for Biologics Evaluation and Research
2024
United States Food and Drug Administration
2024
International Biometric Society
2024
Scientific Consulting Group
2024
American Hospital Association
1990
Adverse events associated with vaccination have been evaluated by epidemiological studies and more recently gained additional attention the emergency use authorization of several COVID-19 vaccines. As part its responsibility to conduct postmarket surveillance, US Food Drug Administration continues monitor adverse special interest (AESIs) ensure vaccine safety, including for COVID-19.
Introduction This study is part of the U.S. Food and Drug Administration (FDA)’s Biologics Effectiveness Safety (BEST) initiative, which aims to improve FDA’s postmarket surveillance capabilities by using real-world data (RWD). In United States, RWD for has been hindered inability exchange clinical between healthcare providers public health organizations in an interoperable format. However, Office National Coordinator Health Information Technology (ONC) recently enacted regulation requiring...
<sec> <title>BACKGROUND</title> Adverse events associated with vaccination have been evaluated by epidemiological studies and more recently gained additional attention the emergency use authorization of several COVID-19 vaccines. As part its responsibility to conduct postmarket surveillance, US Food Drug Administration continues monitor adverse special interest (AESIs) ensure vaccine safety, including for COVID-19. </sec> <title>OBJECTIVE</title> This study is Biologics Effectiveness Safety...
Adverse events (AEs) associated with vaccination have traditionally been evaluated by epidemiological studies. More recently, they gained attention due to the emergency use authorization of several COVID-19 vaccines. As part its responsibility conduct postmarket surveillance, US Food and Drug Administration continues monitor AEs interest ensure safety vaccines, including those for COVID-19.
<sec> <title>BACKGROUND</title> Adverse events (AEs) associated with vaccination have traditionally been evaluated by epidemiological studies. More recently, they gained attention due to the emergency use authorization of several COVID-19 vaccines. As part its responsibility conduct postmarket surveillance, US Food and Drug Administration continues monitor AEs interest ensure safety vaccines, including those for COVID-19. </sec> <title>OBJECTIVE</title> This study is Biologics Effectiveness...