re: Ann: Path Forward For Resubmission of MOX...
For NDA's reviewed by an Advisory Committee (AC) in the period Jan 2012 to May 2012: - there were 12 in total - 6 were supported by the AC - 6 were not supported by the AC - of the 6 supported all were later approved by the FDA - of the 6 not supported all were later received a CRL form the FDA
I was intending to check this for the year but the 5 months tell me what i needed to know: - AC's favour neither positive nor negative outcomes - the AC's recommendation is likely to be echoed by the FDA
All scheduled past and future meetings are here. You need to do a little googling to get the data i summarised above though: http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm
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