ADR CBER stands for Adverse Drug Reactions Case Processing and Biological Effectiveness Research, which refers to a division under the Center for Biologics Evaluation and Research (CBER).
CBER is a regulatory agency within the United States Food and Drug Administration (FDA) responsible for ensuring the safety, efficacy, and availability of biological products. These products include vaccines, blood and blood products, allergenics, and various cell, tissue, and gene therapies.
The ADR CBER division focuses specifically on the adverse drug reactions (ADRs) associated with these biological products. ADRs are unintended or harmful reactions that occur following the administration of a drug or biological product. The ADR CBER division is responsible for receiving and processing reports of ADRs from healthcare professionals, patients, and manufacturers. They collect and analyze data to identify potential safety concerns, evaluate the severity and frequency of adverse reactions, and assess the effectiveness of interventions to mitigate risks.
Additionally, ADR CBER conducts research on the biological effectiveness of these products. This involves studying the mechanisms by which they work, evaluating their safety and efficacy, and investigating any potential adverse effects. The division works closely with other regulatory agencies, such as the Centers for Disease Control and Prevention (CDC), to ensure comprehensive surveillance and monitoring of adverse reactions.
In summary, ADR CBER is a division within the FDA's CBER that focuses on receiving, processing, and analyzing reports of adverse drug reactions associated with biological products. They also conduct research to evaluate the safety and effectiveness of these products.
