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Biotech / Medical : ADVR and ONLY ADVR
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To: KAKALAK who wrote (30)9/23/2000 12:04:37 PM
From: Bernie Bildman  Read Replies (3) of 278
 
I would like to find out exactly what the pre-IND meeting is all about. Are they prompting you insofar as allowing some of the FDA expertise to enter into how and what you submit PRIOR to submission? Is it like a helper meeting, in which they go over much of the IND, or do they simply address what YOU ask for?

I would assume the FDA would WANT any IND submitted to be proper and expert, that the FDA's role should be a helping agent rather than a hindering process. If so, and there are ways - with the FDA looking over your shoulder - to better enable an easier more thorough acceptance process, then this is quite possibly a Godsend for us.

If the failure rate for INDs is as high as reported, is it possible that many companies submit INDs without this oversight? Maybe some companies do not even know about pre-IND meetings.

In any case, let's see if we can come up with something the gives un more information regarding the content of a pre-IND meeting.
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