The purpose of the CBER-CDER Data Standards Strategy is to reinforce the ongoing commitment to the development, implementation, and maintenance of a comprehensive data standards program that will facilitate the pre- and postmarket regulatory review process so that safe and effective medical products are available to patients. The mission of the Center for Biologics Evaluation and Research (CBER) is to ensure the safety, purity, potency, and effectiveness of biological products including vaccines, allergenics, blood and blood products, and cells, tissues, and gene therapies for the prevention, diagnosis, and treatment of human diseases, conditions, or injury.

The mission of the Center for Drug Evaluation and Research (CDER) is to protect and promote public health by helping to ensure human drugs are safe and effective for their intended use, meet established quality standards, and are available to patients.
Together the two centers will leverage their combined resources, talent and expertise to maximize stakeholder collaboration, policy development, and project implementation to develop and use data standards for the effective and efficient review of pre- and postmarket submissions of safety and efficacy data