CDiddy, Well, there is a huge amount of public
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Well, there is a huge amount of public information about FDA procedures methods and requirements (is a public department, remember?).
For example: want to know what a Combo is ?? go to:
https://www.fda.gov/combination-products/abou...n-products
In general, go to:
https://www.fda.gov/
Perusse some documents there (100's of them) and you will know what is the FDA supposed to do and how.
Quote:
I don't think any of us has the faintest clue as to how the FDA works, and what their processes are.
Not so after you do your DD, by the contrary, once one reads few documents "faintest" will not be a good depiction.