On September 25, 2020, FDA issued draft guidance on Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe. This guidance is intended to assist applicants of ANDAs in responding to complete response letters (CRLs) from FDA.
Once an ANDA has been received for review, FDA will perform an assessment to see if the ANDA meets the regulatory requirements for approval. If a deficiency is identified, FDA will communicate this through a CRL. If the applicant wishes to continue with the ANDA, then the applicant should provide all necessary materials to respond to the CRL within 1 year of issuance.
If an applicant does not respond within 1 year of the CRL issuance, FDA may consider this a failure to respond and withdraw the ANDA. To ensure the applicant's awareness of the approaching deadline, FDA will notify the applicant in writing and the applicant will have 30 days from the date of the notification to explain why the ANDA should not be withdrawn or to request an extension of time.
The applicant must address all deficiencies in the CRL by a determined deadline if FDA grants an extension. FDA will notify the applicant in writing and the applicant will have 30 days to respond explaining why the ANDA should not be withdrawn and request another extension of time. Failure to respond within this determined period will result in FDA deeming the ANDA withdrawn.
An applicant can request additional time to respond the to CRL by submitting an amendment to their ANDA. FDA recommends the amendment provide sufficient justification for an extension, which includes: why the applicant needs more time, reasons why one year was not sufficient to respond to the CRL, and the nature of the additional work needed to respond to the CRL. Evidence of progress and a timeline for the extension are encouraged as well.
The amendment will be evaluated along several criteria, including the number, length and reasons for previous extensions, the number and type of deficiencies, and other extenuating circumstances outside the applicant's control. If FDA determines the request is not reasonable, FDA will deem the ANDA withdrawn and notify the applicant of the withdrawal in writing.
Readers are encouraged to read the draft guidance, also available on FDA's website.
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