In this case, it has to do with our blog yesterday (here) and the announcement of how the FDA is embracing “Radical Transparency by Publishing Complete Response Letters.” It turns out that many news outlets jumped on the story as a transformative act, as did we, only to find out that many, if not all, of the CRLs were already available on the FDA’s website. Remember, most of these are older approved NDAs and BLAs, but the CRLs can be found in the approval packages already released by the FDA on its Drugs@FDA site.
While this is not what we thought it might be, it is, nonetheless, a way to easily find CRLs for the 200+ products in the new database without searching through 100s and, in some cases, 1,000s of pages in the FDA summary approval packages.
So, the hype was there but the beef might not have been all that it was made out to be. Perhaps with the approval of more recent applications, access to the CRLs will be faster and, again, easier to locate.
