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You are currently browsing the Drug Kennel weblog archives for the month August, 2011.
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- 2011 505(b)(2) Approvals Now Exceed 505(b)(1) NDA Approvals
- What is an Approved DESI Product?
- Stability Changes coming to ANDAs
- Don’t launch unapproved products after 9/19/2011
- AB Rated 505(b)(2)’s
- 2012 PDUFA User Fees
- Whew! Supreme Court rules generic labels must track RLD
- KV’s Makena Part 4: Statistical versus Clinical Significance
- Patent Cliff Causes Pfizer Cuts
- Role of In Vitro / In Vivo Metabolism Studies in 505(b)(2) Drug Development of Metabolite Products
2012 PDUFA User Fees
Published August 7th, 2011 in News Commentary and Uncategorized. 0 CommentsThe 2012 PDUFA User Fees have been announced in the Federal Register. In summary, the fees are: Applications: Full – requiring clinical data (e.g., Phase 2 or 3): $1,841,500 Not requiring clinical data : 920,750 Supplements requiring clinical data : 920,750 Establishment fee: $520,100 Product: $98,970 For those doing the math, the cost [...]