ANDA Submissions: FDA Revised Refuse-to-Receive Guidance
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ANDA Submissions: FDA Revised Refuse-to-Receive Guidance
The US FDA has recently revised its guidance on standards for refuse-to receive (RTR) an abbreviated new drug application (ANDA). The updated guidance not only offers a broader definition for major deficiencies and but also downgraded four major deficiencies to minor ones to make requirements less cumbersome for industry.
While this guidance document does not provide a comprehensive list of the deficiencies that may lead to an RTR determination by FDA, it identifies certain recurrent deficiencies that have led the Agency to RTR an ANDA.
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Major and Minor Deficiencies
This updated guidance covers discussion on administrative, product quality, bioequivalence and clinical deficiencies that FDA considers to be major deficiencies. The following are some of the examples that are recognized by FDA as major deficiencies:
- Form FDA 356h (356h): An ANDA must have a completed application FDA 356h form. If this form is not included, it is a major deficiency, FDA will RTR the ANDA.
- Submission, Format, and Organization: The ANDA should be organized according to the electronic Common Technical Document (eCTD) format. Also, it should be submitted electronically for GDUFA metric goals to apply to the ANDA.
- Non-Payment of GDUFA Requirements: In some cases if there are outstanding user fee obligations, the regulator will RTR an ANDA. For instance, if an applicant fails to pay the GDUFA Prior Approval Supplement (PAS) fee within 20 calendar days of submission.
- Lack of a Designated U.S. Agent for a Foreign Applicant: This is another example where FDA will RTR an ANDA.
The regulatory document addresses these examples and more to ensure clarity in adhering to the FDA requirements. The guidance further lists examples of minor deficiencies in Appendix A.
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