ANDA Refuse-to-Receive Practices

Refuse-to-Receive Practices - Overview

To ensure content consistency, reduce the time spent by the United States Food and Drug Administration (FDA) reviewers, and minimize the approval timelines for an ANDA, the FDA has set up ANDA Refuse-to-Receive (RTR) guidelines which are vital to the manufacturers/ANDA-holders to be compliant.

‘FDA will send an ANDA Refuse-to-Receive,’ means that it will reject an incomplete ANDA in terms of the RTR ANDA standards, which will lead to a 25% loss in the fee and delay in the approval, which will subsequently lead to a delay in the market entry. Therefore, to submit an error-free application right the first time, an applicant must have a thorough understanding of the FDA’s ANDA submissions.

Interpretation of the FDA’s RTR guidance and adherence to the requirements are challenging for manufacturers/ANDA holders. Freyr can help clients in the preparation, review, and submission of an ANDA as per the Refuse-To-Receive standards and FDA requirements within the timelines.

Refuse-to-Receive Practices - Freyr Expertise

  • 01

    Regulatory and strategic guidance during the development stage on the following:

    • a

      Design specifications/impurity limits in line with the ANDA submissions.

    • b

      Confirmation of composition in line with the IID database for ANDA Refuse-to-Refuse compliance.

    • c

      Guidance on study design of bioequivalence with the Reference Listed Drug (RLD).

  • 02

    Review of source documents/data for their adequacy against RTR ANDA standards.

  • 03

    eCTD conversion in line with ANDA RTR guidance.

  • 04

    Ensuring the API DMF availability for review.

  • 05

    Ensuring all aspects of Refuse-to-Receive compliance during exhibit batches manufacturing.

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