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 may be of your interest, since from September 15th, 2021, the FDA will enforce the Technical Rejection Criteria (TRC) for Study Data by CDER and CBER.
What is the Technical Rejection Criteria?
The TRC consists in an automated validation that occurs upon receipt of a submission. If the submission fails eCTD validations in TRC, CDER/CBER will reject it. TRC has been created by the FDA to ensure study data compliance with the required electronic standards specified in the FDA Data Standards Catalog.
What procedures does TRC apply to?
NDAs, ANDAs, certain BLAs and commercial INDs
Have a look at this brochure for an overview in detail.
For further information, you can contact us at: [email protected]
