Even this holiday is linked to 505(b)(2) activity - at least for me and some of my staff. Dr. Ruth Stevens (Exec. VP and Chief Scientific Officer) , Cindy Phurrough (Dir. Clinical Operations), Stacey Ayres (Sr. Research Associate) and Bill Stoltman (Dir. Regulatory Compliance and QA) and I were together at Duramed on that fateful day May [...]
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You are currently browsing the Drug Kennel weblog archives for the day Monday, May 5th, 2008.
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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