Standardized study data will be required in commercial IND application submissions for clinical and nonclinical studies that start on or after December 17, 2017. On CDER's website you can find Study Data Standards Resources that provides specifications for sponsors regarding implementation and submission of clinical and nonclinical study data in standardized format.
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John Van Hoven, MS
I started this blog to document my thoughts on working in the medical product regulatory field, in particular my experiences working with the FDA. I hope you find it somewhat helpful. Archives
August 2016
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