DSAC CBER stands for Division of Standards and Conformance Assessment – Center for Biologics Evaluation and Research. It is a regulatory division of the U.S. Food and Drug Administration (FDA) that is responsible for assessing and ensuring the safety, efficacy, and quality of biologic products.
The Division of Standards and Conformance Assessment (DSAC) within CBER focuses on the development and implementation of standards, procedures, and policies related to the regulation of biologic products. This division plays a crucial role in setting and maintaining high standards for the evaluation, manufacturing, and quality control of biologics.
The DSAC CBER division conducts inspections, audits, reviews, and assessments of biologic manufacturing facilities, laboratories, and products to ensure compliance with applicable regulations, guidelines, and quality standards. It also works closely with other regulatory agencies, industry experts, and stakeholders to develop and harmonize standards for biologic products. By promoting standardization, DSAC CBER aims to enhance regulatory oversight, streamline processes, and facilitate the development and availability of safe and effective biologics for public health purposes.
In summary, DSAC CBER is a regulatory division of the FDA that focuses on the establishment and enforcement of standards and conformance assessment in relation to biologic products. Its mission is to safeguard public health by ensuring the quality, safety, and efficacy of these specialized therapies through regulatory compliance and standardization.
