heres a little offtake from an article in regards to pre IND meetings with the FDAThe pre-IND meeting typically includes a discussion of scientific and regulatory aspects of the drug as they relate to safety and/or potential clinical hold issues. Sponsors are strongly encouraged to take advantage of the pre-IND meeting for the following reasons:
https://www.nuventra.com/resources/blog/fda-pre-ind-meeting-guide/
- -The information gained from the meeting can help ensure a complete IND application is submitted and potentially help avoid clinical holds
- -The meeting presents a formal opportunity to gather the FDA’s perspectives, recommendations, and preliminary agreement (or disagreement) on critical aspects of your development program
- -The meeting is an opportunity to build a constructive relationship with the FDA
- -No fees are required for this meeting
- source
Ann: Notice under Section 708(A) of the Corporations Act, page-3
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