Good morning, CMC colleagues -
the FDA published final guidance on their program for the recognition of voluntary consensus standards here. I look forward to discussing how you think this will be adopted and implemented. Perhaps an interesting topic for next year's Summer Scientific Forum, @Sachin Lohani and @Maria Cruanes? I suspect that there is catching up to do on the difference between compendial and voluntary consensus standards, as well as the concepts of primary and secondary standards.
Cheers,
Tina
------------------------------
Tina Morris Ph.D.
Executive Director
AAPS
Arlington VA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------