In what year was the CDER Data Standards Program established?

The CDER Data Standards Program was established in 2010 to enhance the quality of data received by the FDA, ensure inter-operability among data systems, and facilitate the review process for regulatory submissions. The initiation of this program was part of ongoing efforts to improve regulatory efficiency and advance the adoption of standardized data formats in the submission of clinical trial data. This initiative aligns with the FDA's goals to leverage data standards to foster innovation and enhance the regulatory experience. Establishing a solid framework for data standards ensures consistency and clarity, helping both the FDA and pharmaceutical companies in managing and reviewing submitted data effectively.