Tuesday, January 27, 2015 7:59:09 AM
Regarding advisory committee voting, subsequent to the Titan vote a company received a drug approval which was not recommended by such committee.
This is my mind makes the whole subject of committee review a potentially academic process. It appears that FDA approvals may be questionable as far as what may influence an acceptance or denial.
My opinions are jaundiced by the Iloperidone episode which if you were around at the time I'm sure you recall. A denial followed by an approval. My recollection is that nothing changed between the denial and approval.
So my concern, at least in my mind, is well founded.
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