Search results with tag "Study data technical rejection criteria"

FDA Study Data Technical Rejection Criteria (TRC): What ...

Document (eCTD) web page, Specification for eCTD Validation Criteria, and within the TRC document Warning notice will be sent between March 15th and Sept. 15th, 2021 for submissions failing eCTD validations in TRC Starting Sept 15th, 2021, if a submission fails eCTD validations in TRC, CDER and CBER will reject WHAT’S NEW

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