Are you planning to send a submission to the FDA?
Will this submission contain study data?
If the answer to these 2 questions has been yes, this brochure may be of your interest, since last year the FDA implemented the Technical Rejection Criteria (TRC) for Study Data by CDER and CBER.
Have a look at this brochure for an overview in detail:
For further information, you can contact us at: firstname.lastname@example.org