re: Ann: Path Forward For Resubmission of MOX... For NDA's...

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