By popular request, I am adding this scorecard to my blog to track FDA 505(b)(2) approval activity. I am going to use calender year, not FDA’s fiscal or other definitions of year, so my list may not line up with an FDA list. My purpose is to provide the community with a listing that has links to relevant documents and postings so we can all learn about the evolution of the 505(b)(2) process.
A caveat: FDA does not always identify an application as a 505(b)(2) - some FDA approval letters just state 505(b). I try to make an informed judgement about whether it is a (1) or (2) based on information contained in the FDA site or from sponsor information.
Regarding hyperlinks to FDA website. By now everyone knows that FDA made a major overhaul to its website and broke most of the links. If you cannot find something, please contact me and I’ll try to help.
Please feel free to comment.