(Total Views: 588)
Posted On: 09/15/2020 11:38:09 AM
Post# of 149431
Multi-disciplinary refers to the different fields the FDA professionals that are reviewing the BLA submission work in. I don't think it has anything to do with reviewing multiple indications at once.
Here is a link to a quiz provided by the FDA that lists a few disciplines in a multidisciplinary review team as being chemists, clinical pharmacologists and statisticians.
https://www.accessdata.fda.gov/scripts/cderwo...mp;fw1pk=1
Here is a link to a quiz provided by the FDA that lists a few disciplines in a multidisciplinary review team as being chemists, clinical pharmacologists and statisticians.
https://www.accessdata.fda.gov/scripts/cderwo...mp;fw1pk=1
(1)
(0)
Scroll down for more posts ▼