Consultation: Transition to eCTD only for prescription ...
eCTD formatting questions should be sent to DMID-RASeCTD@tech-res.com, with the RAS in cc. ... (FDA) Regulations, as applicable: 21 CFR Part 50 (Protection of Human Subjects), 21 CFR Part 54 (Financial Disclosure by Clinical Investigators), 21 CFR Part 56 (Institutional Review Boards), 21 CFR Part 11, and 21 CFR Part 312 (Investigational New ... ................
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