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You are currently browsing the Drug Kennel weblog archives for the day Thursday, August 7th, 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
Residual Solvents - New FDA Draft Guidance
Published August 7th, 2008 in Formulation Issues and News Commentary. 0 CommentsThe USP established a new test requirement for control of residual solvents in finished dosage forms. The new test is in the General Chapter <467> “Residual Solvents” [Sorry no link - password protected]. The test became official July 1, 2008. In turn, on August 5, 2008 the FDA issued a draft guidance stating that all NDA and [...]