Search
About
You are currently browsing the Drug Kennel weblog archives for the day Thursday, February 19th, 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

Use of Foreign Trial Data
Published February 19th, 2009 in News Commentary. 0 CommentsNo, I don’t have a crystal ball. Yesterday, I posted comments on the factors FDA can use to determine what foreign trial data it can use (extrapolate) to US populations and medical practice. Today, an article entitled “Ethical and Scientific Implications of the Globalization of Clinical Research” appears in the New England Journal of Medicine [...]