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, due to the implementation by the FDA of 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