Maybe the title should have a question mark after it - will the review time for a first generic drop? FDA plans to do so - it announced the Generic Initiative for Value and Efficiency (GIVE). Basically, the Office of Generic Drugs will try to review within 6 months an application for a first generic [...]
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You are currently browsing the Drug Kennel weblog archives for the day Monday, October 8th, 2007.
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- Failed 505(b)(2)?: Vivus’ Qnexa
- Will We Have Generic User Fees? Public Meeting To Be Held.
- Lannett’s Morphine Sulfate Oral Solution: 505(b)(2) or 505j?
- Generic Lovenox – 505j or 505(b)(2)
- New User Fees for 2011
- Still submitting paper ANDA applications?
- What should a license cost?
- Avandia: Who Won?
- Advisory Committee Meeting: Rosiglitazone
- The skinny on a potential new treatment of obesity