Articles tagged with “ind-application”

eCTD Submission Guide: IND & NDA Application Requirements

A complete guide to the IND & NDA eCTD submission process. Learn the eCTD format, CTD modules, FDA requirements, and the transition from eCTD v3.2.2 to v4.0.

35 min read

1/13/2026

ectd submission regulatory affairs ind application nda application ctd modules fda requirements ectd v4.0

Investigator-Initiated Trials (IITs): A Guide to Sponsorship

Learn what Investigator-Initiated Trials (IITs) are and the regulatory responsibilities clinicians face as a Sponsor-Investigator in academic clinical trials.

40 min read

11/22/2025

investigator initiated trial sponsor-investigator clinical trial sponsorship academic clinical trials gcp guidelines fda regulations ind application

What is an Investigator's Brochure (IB)? A GCP Guide

Learn what an Investigator's Brochure (IB) is, its required content per ICH GCP guidelines, and its critical role in assessing risk for clinical trials.

35 min read

11/19/2025

investigator's brochure clinical trials gcp ich e6 regulatory affairs ind application drug development investigational product