Another example of the importance CMC was reported in the news today. Warner Chilcott plc received a complete response letter from the FDA. Their “low dose” oral contraceptive NDA was the file in question. The FDA inspection of the third-party drug substance manufacturing facility and control testing laboratory used to support the application [...]
Search
About
You are currently browsing the Drug Kennel weblog archives for the day Friday, January 29th, 2010.
Longer entries are truncated. Click the headline of an entry to read it in its entirety.
Latest
- 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