I had a call from a client who wondered if he could launch a new ‘DESI’ product. He had just read the FDA’s recent announcement that it would take immediate enforcement action on any unapproved drug introduced into the market after September 19, 2011. So, the question he asked was, is his “DESI” drug an [...]
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You are currently browsing the Drug Kennel weblog archives for the month October, 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
Stability Changes coming to ANDAs
Published October 4th, 2011 in ANDA's and News Commentary. 0 CommentsThis post comes from D.C. where I am attending the GPhA Fall Technical Conference. We just completed a presentation by FDA’s Glen Smith. He detailed the proposed new stability requirements for ANDA drug products. It is essentially the adoption of ICH Q1A. For readers of this blog, we know that 505(b(2) NDA’s must have 12 months [...]