Common Pitfalls in Preparing an IND Application
Advarra
JUNE 28, 2022
Leaving Out Pertinent Chemistry, Manufacturing, and Controls (CMC) Details. Using nonclinical data or manufacturing information that doesn’t adequately support the clinical protocol hurts the IND application. It may take 12-14 months to complete the IND package, not including the time commitment for the pre-IND.
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