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Published on FierceBiotech (http://www.fiercebiotech.com)

Blogster sees lessons in FDA approvable letters

By admin
Created Feb 21 2008 - 7:59am

The blogster Eye on FDA has tracked down and posted every approvable letter [1] he's heard about for 2007. The crop of letters highlights some particular challenges for new drugs targeting ADHD, pain and depression. The 29 letters marked a record for the FDA, particularly for multiple letters covering the same therapy. "And even though we are in a severe "risk-averse" environment, one could say that efficacy was every bit as much a factor as safety in the 2007 crop of letters."

- read the blog report [2]

Related Articles:
2007 FDA approvals. Report [3]
FDA more friendly to approvable than approved. Report [4]
'07 drug approval record raises worries. Report [5]
Dry spell or parched desert for NME approvals? Report [6]
New drug approval lags in 2007. Report [7]


Source URL:
http://www.fiercebiotech.com/story/blogster-sees-lessons-in-fda-approvable-letters/2008-02-21