During drug development and/or during the review of a submission, FDA regulations may change. Changes can be made immediately or they can appear as drafts. Proposed regulations or guidances are presented in draft form to seek public comment. In any case, it is important to monitor any changes - actual or proposed, to assure the success of [...]
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You are currently browsing the Drug Kennel weblog archives for the day Tuesday, January 27th, 2009.
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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