FDA Study Data Standards in eCTD: What You Need to Know about the New Technical Rejection Criteria

January 11, 2017 10:00–11:00 Eastern Time (US & Canada)

This webinar will provide an update on FDA’s requirements for the submission of standardized study data in NDAs, BLAs, ANDAs and INDs. Further, the webinar presents the core set of technical criteria that will be the basis for technical rejection of applications that do not conform to the required study data standards.

Specifically, topics addressed will be:
• FDA’s electronic study data standards requirements in submissions
• Exemptions to the electronic study data standards requirements
• Understanding of the key validation criteria for the rejection of submissions not in conformance with the required study data standards
• Consequences for failure to submit study data in conformance to the required study data standards
• Study Data Technical Conformance Guide update on the use of Trial Design Model and Trial Summary Domain

Presenters: Ginny Hussong and Ron Fitzmartin of the FDA

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