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Biotech / Medical : Indevus Pharmaceuticals (NasdaqNM:IDEV) -- Ignore unavailable to you. Want to Upgrade?


To: kenhott who wrote (73)6/6/2008 1:34:28 PM
From: Biomaven  Read Replies (1) | Respond to of 78
 
If the FDA doesn't accede to a request for an AC they have to state their reasons in writing and their adverse decision is subject to review up the chain of command at the FDA. I think that in a case like this (a marginal-looking safety issue) they would pretty much have to accede to the request for an AC.

fda.gov

Of course there is a potential cost to pissing-off the FDA by trying to have the decision overturned - but given the turnover at the FDA these days any folks you piss off probably won't be there that long anyhow. :)

Maybe we can get Mark McClellan back at the FDA under the next administration given his brother just broke ranks with the current administration.

Peter