The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?
Camargo
AUGUST 22, 2021
The FDA also issued the Study Data Technical Conformance Guide , which contains detailed information on how to meet the requirements contained in the DSC. 3.1.1: Bioavailability Study Reports. 3.1.1: Bioavailability Study Reports. Where Are the Technical Rejection Criteria for Study Data Applied? Validation Code.
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