AI
Wednesday, July 19, 2023 1:16:09 PM
Chiugray, fortunately there are several teams of people and departments at the FDA that are responsible for reviewing the different modules that make up the entire BLA submission.
I believe that Les indicated that there were 27 different modules, that comprised the entire BLA / MAA submission package.
As a result, these 1.7 million pages are separated into 27 different modules, and several different departments within the FDA will be responsible for reviewing their assigned section(s) of the full submission package.
Here is what ChatGPT says regarding this question:
I believe that Les indicated that there were 27 different modules, that comprised the entire BLA / MAA submission package.
As a result, these 1.7 million pages are separated into 27 different modules, and several different departments within the FDA will be responsible for reviewing their assigned section(s) of the full submission package.
Here is what ChatGPT says regarding this question:
Bullish
