To ensure consistency in the content, to reduce the time that would be spent by FDA reviewers, and to minimize the approval timelines in the substantially complete ANDA, FDA has set up Refuse to Receive (RTR) ANDA guidelines which are vital to the manufacturers/ANDA holders to be compliant with for an ANDA.
‘FDA will Refuse to Receive ANDA,’ means that it will reject a substantially incomplete ANDA in case of non-compliance to RTR ANDA standards, which will lead to a loss of 25% of ANDA fee and delay in receiving the approval, and that will subsequently lead to a delay in market entry. Therefore, to submit an error-free application right at the first time, an applicant must have complete understanding of FDA’s Refuse-to-Receive standards for ANDA.
Interpretation of FDA’s RTR guidelines and adhering to the requirements is quite challenging for the manufacturers/ANDA holders. Freyr can help clients in the preparation, review, and submission of ANDA as per the RTR standards and FDA requirements within the timelines.
Regulatory and strategic guidance during the development stage on the following:
Design specifications/impurity limits in line with RTR.
Confirmation of composition in line with IID database for RTR compliance.
Guidance on study design of bioequivalence with RLD.
Review of source documents/data for their adequacy against RTR standards.
eCTD conversion in line with FDA guidance.
Ensuring the API DMF availability for review.
Ensuring all aspects of RTR compliance during exhibit batches manufacturing.