Workshop on Drug Analysis Data Standards Advancement

Federal Register notice: FDA has announced a 6/12 public workshop entitled “Advancing the Development and Implementation of Analysis Data Standards: Key Challenges and Opportunities.” Mandated by the current user fee agreement, the workshop is intended to discuss challenges and opportunities (XXX DELETE XXX)in drug development and regulatory review. Items for discussion will include stakeholder experience implementing analysis data standards in electronic submissions. Input will be sought on challenges and opportunities to: (1) Improve data submission efficiency, predictability, and quality; (2) support data traceability; and (3) support analysis data standards implementation. Input will also be sought on approaches to reduce the variability of formats used to submit study data, improve the integration of data across studies, and enable the use of data from sources other than traditional clinical trials. To view the notice, click here.