I enjoy eating Chinese food with a group, because I can get a sample from each person’s plate. Such as in 505(b)(2) submissions, you can pick and choose parts of different RLD’s for your submission.
A reader was surprised when I previously commented that a 505(b)(2) submission can have more than one RLD. As long as the information is supprortive of your [...]
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You are currently browsing the Drug Kennel weblog archives for the day Tuesday, May 27th, 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