ANDA Refuse-to-Receive Practices

Freyr offers expert guidance on FDA's ANDA Refuse-to-Receive standards, ensuring compliant submissions and minimizing approval delays. Our comprehensive services cover strategic development guidance, document review, and eCTD conversion to help manufacturers navigate complex RTR requirements efficiently.

ANDA 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.

ANDA Refuse-to-Receive Practices - Expertise

  • Regulatory and strategic guidance during the development stage on the following:
    • Design specifications/impurity limits in line with the ANDA submissions.
    • Confirmation of composition in line with the IID database for ANDA Refuse-to-Refuse compliance.
    • Guidance on study design of bioequivalence with the Reference Listed Drug (RLD).
  • Review of source documents/data for their adequacy against RTR ANDA standards.
  • eCTD conversion in line with ANDA RTR guidance.
  • Ensuring the API DMF availability for review.
  • Ensuring all aspects of Refuse-to-Receive compliance during exhibit batches manufacturing.
ANDA Refuse-to-Receive Practices

Celebrating Customers Success

 

Medicinal Products

Regulatory Affairs

India

Thank you for the timely support over the weekend, which allowed us to resubmit quickly after being notified. This continuously demonstrates Freyr's commitment towards our company’s milestones.

Director - Global Regulatory Affairs – Operations

India-based, Global Top Generic Pharma Company

 

Medicinal Products

Publishing

UK

I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.

Thank you Freyr team for a job well done!

Sr. Director, Head of Regulatory Operations

Ireland-based, Global Specialty Pharmaceutical Company

 

Medicinal Products

Regulatory Affairs

USA

Please relate to the team the excellent job they have done on the IND reactivation. Specifically, the high-quality module 3, written by Freyr. It was very comprehensive, very few revisions were required, and we had no questions from Health Canada or FDA. No CMC questions: that was a first for me. So very responsive to my many requests, which I am sure can be frustrating but always helpful while producing excellent work.

Thank you for always being available and responding quickly and comprehensively to all my requests.

What a great team you have, Freyr.

Lynne McGrath

Regulatory Consultant

 

Medicinal Products

Regulatory Affairs

USA

Congratulations!!! ​

Thanks for your great support for a successful ANDA filing, especially to the publishing team. Heartfully appreciate their last hours of hard work.

Assistant Manager​

US-based, Leading, Complex Generic Pharmaceutical Products Company​

 

Medicinal Products

Regulatory Affairs

USA

Thank you all for the great support!​

CEO

US-based, Leading Innovative Pharmaceuticals Company​

 

Medicinal Products

Regulatory Affairs

USA

The ANDA receipt has been received! Thank you very much for your hard work, patience, and support for our work over the last couple of months. We are delighted that we were able to meet the timeline and hit an important corporate goal of our young company. ​

Thank you again, and we look forward to working with your team on the next project!

Senior Director of Business and Product Development​

US-based, Leading Innovator Pharmaceuticals Company​