Once the clinical development plan is established, the CMC, regulatory and medical communication plans can be matched up. We use MS Project to develop a high-level overall plan. MS Project then can be used to generate cash flows and Gantt charts. This information can be used by the sponsor to determine if the project is financially feasible.
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You are currently browsing the Drug Kennel weblog archives for the day Wednesday, January 16th, 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