PharmaCyte Biotech Inc (PMCB)

[Triple9]

YSK the FDA approval process for Biologics is different from the regular Drug approval process. In fact, while drugs are approved by the FDA's Center for Drug Evaluation and Research (CDER), new biologics are approved by The Center for Biologics Evaluation and Research (CBER).

https://www.focr.org/fda-regulatory-policy

CDER: https://www.fda.gov/drugs/developmentapprovalprocess/
CBER: https://www.fda.gov/biologicsbloodvaccines/developmentapprovalprocess/

FDA Biologics FAQ: https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/ucm113522.htm

I found these slides (from 2014, so some things may have changed) comparing the different Drug and Biologics approval processes:

https://www.slideshare.net/gas25/usfda-nda-vs-bla

Note slide 39, which indicates that the facility producing the biologics must also be reviewed and approved. I suspect this is one of the reasons $PMCB switched to Eurofins to produce the master and working cell banks. Eurofins surely already has had an FDA Product Standards facilities inspection as it already does work for 9 of the 10 largest pharma companies in the world.