Q&A: The IND Journey Phase I – Navigating Success
Advarra
JULY 19, 2022
The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting? The term drug substance and drug product are found in the NDA regulations 21 CFR 314.3,
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