OIT CBER, also known as the Office of Information and Technology, Center for Biologics Evaluation and Research, is a specialized division within the U.S. Food and Drug Administration (FDA) that focuses on information technology related activities in the field of biologics evaluation and research.
The Office of Information and Technology (OIT) is responsible for overseeing the strategic planning, development, implementation, and maintenance of information systems and technology infrastructure within the FDA. It aims to modernize and enhance the agency's ability to regulate and evaluate various products, including biologics.
The Center for Biologics Evaluation and Research (CBER) is a branch of the FDA that regulates biological products, such as vaccines, blood products, and gene therapies, to ensure their safety, effectiveness, and quality. CBER is also involved in the evaluation and approval of clinical trials related to biologics.
Within OIT CBER, the focus is on the integration of advanced information technologies into the evaluation and research processes related to biologics. This may include the use of data analysis, computer modeling, electronic records management, and other digital tools to streamline and enhance the regulatory processes.
Overall, OIT CBER plays a crucial role in leveraging technological advancements to facilitate the evaluation, approval, and regulation of biologics, ultimately ensuring the safety and efficacy of these products for public health.
