Bioequivalence and Bioavailability Forum

Hi Helmut,

❝ Definitely. Did you notice the term “guidance” instead of “guideline”? I have learned from John that – according to FDA’s thinking – the latter is considered more binding that the former. This was one of the reasons renaming the “Note for Guidance on Investigation of Biavailability and Bioequivalence” to “Guideline on Investigation of Bioequivalence”.

Yes, when I was a regulator noone was able to tell the regulatory status difference between a Guideline, Note for Guidance, Points to Consider and Q&A. The commission had no idea either, I think, because of lack of definitions in dir. 2001/83 etc. So the EMEA decided to abandon PtC's and NfG's altogether.
I guess that makes it all a lot simpler. Unless of course you deal with regulators who find it hard to tell the difference between personal subjective opinion and universal law. Fortunately, this of course does not apply in the case of any member of the PK subgroup notch notch wink wink