GREY:IPHAF - Post by User
Post by
tcdrugson May 05, 2010 12:47am
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Post# 17063563
fda approval rates
fda approval rates
https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm127155.htm
"The approval rate for Standard review applications was similar regardless of company size (38% for large vs. 35% for small). However, the difference in approval rate on Priority applications was much more significant (78% for large vs. 48% for small), and accounts for the greater first-cycle success for large companies. Booz Allen speculates that this substantial difference may indicate that smaller companies have more deficiencies in their applications and have difficulty managing the compressed, six-month review timeframe of the Priority review, while larger companies with more resources are better able to respond to FDA concerns and issues in a timely fashion."