STUDY DATA BY FDA

June 10, 2022

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:

STUDY DATA FDA

For further information, you can contact us at: info@asphalion.com

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