Search
About
You are currently browsing the Drug Kennel weblog archives for the day Wednesday, September 30th, 2009.
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
Biosimilars - An introduction
Published September 30th, 2009 in News Commentary. 1 CommentRelated to the current frantic activity regarding health care in the US, there is a smaller struggle concerning biosimilars that in many ways mirrors the larger health care struggle.
Drug products made from small molecules are regulated primarily by the Food, Drug and Cosmetic Act (FD&CA) and through regulations promulgated by the FDA Center for Drug [...]