FDA has announced that it will hold a small business workshop on April 29, 2008 in Dallas Texas. We’ve been to a similar workshop in Washington, D.C. The FDA has a number of presentations but the discussions and questions are very limited. ATtendance is limited to 150 people and it is almost always sold out. [...]
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You are currently browsing the Drug Kennel weblog archives for the day Monday, March 31st, 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