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Re: KMBJN post# 125840

Tuesday, 10/18/2016 2:20:46 PM

Tuesday, October 18, 2016 2:20:46 PM

Post# of 146201
No they don't require it. Hence the word "should" and not "must." Then there is that pesky actual FDA code:

Code of Federal Regulations Title 21 PART 312 -- INVESTIGATIONAL NEW DRUG APPLICATION
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=312.23

It only asks for a vague description "if known," otherwise leave that section of the IND application blank.

This isn't a very difficult concept. Thank you, however, for links to Swiss companies and all sorts of other nonsense except for the FDA code itself which says zero about efficacy requirements -- because there aren't any.

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