Competitive Products Review/Clinical Marketing Assessment
This section includes an assessment of the existence of a medical need and the ability of the proposed drug to compete with existing and pipeline agents. At Camargo we deeply believe that good science = good business. In practice, this means that simply getting FDA approval isn’t enough. The drug [...]
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You are currently browsing the Drug Kennel weblog archives for the day Wednesday, December 12th, 2007.
Longer entries are truncated. Click the headline of an entry to read it in its entirety.
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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