U. S. government officials both inside and outside of FDA have acknowledged that the Agency currently lacks the resources, both financial and human, to adequately monitor the materials going into products being used in the United States. The answer? In the case of the somewhat notorious contaminant melamine, the answer is to make regulated industry [...]
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You are currently browsing the Drug Kennel weblog archives for the month August, 2009.
Longer entries are truncated. Click the headline of an entry to read it in its entirety.
Latest
- 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
FDA halts marketing of topical ibuprofen products
Published August 24th, 2009 in News Commentary. 0 CommentsNoting that topical ibuprofen drugs are not included in any OTC monograph or the subject of any approved NDA, the FDA has issued warning letters (click hyperlink to FDA warning letter) to eight manufacturers/distributors. This action is continuing good news to DESI producers who worry that getting an NDA may not cause FDA to remove non-NDA [...]