OD CBER stands for Office of Drug Control Policy (OD) within the Center for Biologics Evaluation and Research (CBER). The Office of Drug Control Policy is a component of the Food and Drug Administration (FDA), which is an agency of the United States Department of Health and Human Services (HHS).
The CBER is responsible for regulating biological products, including vaccines, blood products, gene therapies, and certain medical devices. The OD CBER specifically focuses on drug control policy matters related to the evaluation and regulation of biological products.
The role of OD CBER is to develop and implement policies and initiatives that ensure the safety, effectiveness, and quality of biological products. This includes conducting research, establishing regulatory guidelines and standards, reviewing applications for product approval, monitoring post-market safety, and overseeing compliance with regulatory requirements.
OD CBER works collaboratively with other FDA offices, government agencies, industry, healthcare professionals, and the public to promote public health and safeguard the nation's drug supply. They engage in regulatory activities such as inspecting manufacturing facilities, monitoring adverse events related to biological products, and addressing regulatory concerns or potential violations.
In summary, OD CBER is the office within the FDA's Center for Biologics Evaluation and Research that focuses on drug control policy matters related to the evaluation and regulation of biological products, ensuring their safety and effectiveness for public use.
