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 [...]
Search
About
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
- FDA’s DAARP is now DAAP, DPAP is now DPARP
- Exalgo Approved
- Do Not Neglect Your Third-Party Drug Substance Manufacturer
- Proposed FDA rule would make Sponsors more responsible for data integrity - way more responsible
- Spending on DTC Ads
- Generic Approvals Taking Longer
- Can and Should ANDA Labeling Differ from the RLD?
- Roche’s Actemra Approved For RA After Year’s Delay
- News on the Biosimilar Front
- Pediatric Assessments in Drug Development: timing in Europe vs. US
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 [...]