Common Pitfalls in Preparing an IND Application
Advarra
JUNE 28, 2022
There are benefits to holding a pre-IND meeting, such as: Verifying the appropriate animal model is used to determine product safety. Leaving Out Pertinent Chemistry, Manufacturing, and Controls (CMC) Details. It may take 12-14 months to complete the IND package, not including the time commitment for the pre-IND.
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