Beginner’s Guide to Pre-IND Meetings
This blog provides a beginner’s overview of what the pre-IND meeting is and how to prepare for one.
The IND Journey Phase I – Navigating Success
Explore strategies for advancing investigational new drug (IND) submissions and a comprehensive guide through Phase I of the IND journey.
A Beginner’s Guide to IND Safety Reporting Under 21 CFR 312(c)
Learn how to ensure compliance with FDA 21 CFR 312.32, and explore Advarra solutions that support efficient and compliant safety reporting.
Pitfalls of Chemistry, Manufacturing, and Controls in Investigational New Drug Preparation
Submitting an IND application for the first time? Consider three common CMC pitfalls that may impact submission.