CBER/CDER Study Data Standards for Regulatory Submissions Position Statement
FDA recognizes the investment made by sponsors over the past decade to develop the expertise and infrastructure to utilize Clinical Data Interchange Standards Consortium (CDISC)[1] standards for study data. T
FDA recognizes the investment made by sponsors over the past decade to develop the expertise and infrastructure to utilize Clinical Data Interchange Standards Consortium (CDISC)[1] standards for study data. The submission of standardized study data enhances a reviewer’s ability to more fully understand and characterize the efficacy and safety of a medical product.
The Prescription Drug User Fee Act (PDUFA V)[2] Performance Goals state that FDA will develop guidance for industry on the use of CDISC data standards for the electronic submission of study data in applications. In the near future, FDA will publish guidance that will require study data in conformance to CDISC standards.[3]
FDA envisions a semantically interoperable and sustainable submission environment that serves both regulated clinical research and health care. To this end, FDA will continue to research and evaluate, with its stakeholders, potential new approaches to current and emerging data standards. FDA does not foresee the replacement of CDISC standards for study data and will not implement new approaches without public input on the cost and utility of those approaches.
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Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Managing Side Effects and Dosing in Off-Label GLP-1 Use with Help from Real-World Evidence
July 18th 2025Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how real-world data is helping researchers navigate gastrointestinal side effects, dose flexibility, and long-term tolerability in off-label GLP-1 use.
Anselamimab Misses Primary Endpoint in Phase III CARES Trials for AL Amyloidosis
July 17th 2025In the Phase III CARES trials, anselamimab did not meet the primary endpoint for advanced-stage AL amyloidosis, but a prespecified subgroup analysis revealed meaningful improvements in survival and cardiovascular outcomes.
