gowdardivya
Registered
Dear Community -
I am in the process of writing a presub and I would like to see if anyone can share a redacted copy of the presub so that I can get an idea on format and contents. I did review the FDA guidance document for general format and have an idea. But it will be great to see an example! Thanks so much!
I am in the process of writing a presub and I would like to see if anyone can share a redacted copy of the presub so that I can get an idea on format and contents. I did review the FDA guidance document for general format and have an idea. But it will be great to see an example! Thanks so much!