No, 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 [...]
Archive for February, 2009
Use of Data from Foreign Clinical Studies for US Approval
Published February 18th, 2009 in 505(b)(2) Process and How to:. 0 CommentsTwo major factors drive clients to consider running trials in foreign countries - cost and recruitment. The question we often get is: can we use the data from such trials in a US submission? The answer is: quite possibly. I won’t address the conduct of supporting trials in foreign countries, rather, this post addresses the conduct [...]
For the first time, FDA’s new drug division has approved more 505(b)(2) drugs than those submitted via 505(b)(1). In 2006 and 2007, the percentage of 505(b)(2) drug approvals went from 20 to 43%, respectively. The FDA publishes a list of drugs approved each year and this list for approvals through November, 2008 has a column [...]
Dexlansoprazole approved for the treatment of GERD
Published February 2nd, 2009 in 505(b)(2) Process and News Commentary. 0 CommentsThis past Friday, 1/30/2009, the FDA approved Takeda Pharmaceuticals North America Kapidex (dexlansoprazole) for the treatment of gastroesophageal reflux disease (GERD). Kapidex is an enantiomer of lansoprazole (Prevacid). In addition to the change in enantiomer, Kapidex is formulated with two type of enteric-coated granules to provide two separate releases of medication. According to the Takeda [...]
Generic Biologics
Published February 28th, 2009 in News Commentary. 0 CommentsThis past week I attended the 2009 Generic Pharmaceutical Association annual meeting. Much time was devoted to the issue of generic versions of biologics. Adding to the debate was the what to call these drugs. The GPhA prefers to call them biosimilars (nice ring to sameness) or biogenerics and BIO prefers to call them follow-on biologics [...]