Bioequivalence and Bioavailability Forum

Happy New Year John!

❝ Laszlo (Endrenyi) said Hi. I had dinner with him while I was in Toronto Canada.

THX! I have to wait until May to meet him again…

❝ ❝ ❝ […] is going to be comes in effect from 02nd January 2014.

❝ ❝ Where do you get this information from? It’s a draft and 20 comments have been submitted so far..

❝ Unfortunately CROs and companies (most if not all) treat the draft guidance as official, usually...

Yes, right. In this particular case I’m completely with the FDA. Must be a nightmare to review all this “creative inventions” (attempts to get failed studies through). So CROs should take this (draft) guidance seriously.
My original question was about the “effective date = today”, which I could not find anywhere at FDA’s site.