Multi-disciplinary refers to the different fields
Post# of 148126
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Posted On: 09/15/2020 11:38:09 AM
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
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