To ensure the consistency in the content, to reduce the time that would be spent by FDA reviewers and to minimize the approval timelines to be included in the substantially complete ANDA, FDA have set up Refuse-To-Receive guidelines, which are very vital to the manufacturers/ANDA holders to be complaint with all RTR standards for an ANDA.
FDA will refuse to receive the ANDA that means will reject the substantially incomplete ANDA in case of non-compliance to RTR standards, which will lead to loss of 25% of ANDA fee and also delay in receiving the approval subsequently delay in market entry. Therefore, to submit error-free application right at 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 client in preparation, review and submission of ANDA as per RTR standards and FDA requirements within the timelines.
Regulatory strategic guidance during the development stage on followings
Design specifications/impurity limits in line with Refuse-To-Receive
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 Refuse-to-receive standards
eCTD conversion in line with FDA guidance
Ensuring the API DMF availability for review
Ensuring the all aspects of Refuse-To-Receive compliance complaint during exhibit batches manufacturing
Expertised and experienced resources to handle various dosage forms for RTR