Here is a question to those knowledgeable on the FDA’s Pre-IND process:
The FDA process guidance states that it agrees to a pre-IND meeting based on certain conditions and if grated the meeting requestor should provide meeting materials for the meeting per this guidance:
https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/small-business-and-industry-assistance-frequently-asked-questions-pre-investigational-new-drug-ind
Per today’s Ann, FDA aims to respond to IHL by 21st of April.
Is a meeting recalling happening or will FDA will review the information package and provide IHL a response by 21st of April? Or will a face-to-face (or video) meeting take place on or before 21st? I am unclear on that part. Appreciate some clarification.
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- Ann: IHL-675A Pre-IND meeting with FDA update
Ann: IHL-675A Pre-IND meeting with FDA update, page-22
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