The FDA’s Technical Rejection Criteria for Study Data: Does Your eCTD Submission Comply?
Camargo
AUGUST 22, 2021
The first two were published in December of 2014: Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act mandates that NDAs, ANDAs, and INDs be submitted in electronic format. 3.1.1: Bioavailability Study Reports. 3.1.1: Bioavailability Study Reports.
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