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USFDA's Guidance: Failure to Respond to an ANDA Complete Response Letter Within the Timeframe


An abbreviated new drug application (ANDA) contains data that is submitted to the FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower-cost alternative to the brand-name drug it references.

This guidance aims to help streamline the ANDA assessment process and support FDA’s GDUFA performance commitments.


This guide provides information and recommendations regarding potential courses of action for an ANDA applicant after the issuance of a complete response letter (CRL) as well as the actions that FDA may take if the applicant fails to respond to a CRL.


This guidance also identifies information that an applicant may submit in its request for an extension to respond to a CRL as well as a non-exhaustive list of factors that the FDA generally intends to consider in determining whether such a request is reasonable.


In this guidance, which finalizes the draft published in September 2020, FDA added an appendix that provides examples of factors that the FDA could consider as the basis for concluding an applicant’s request for an extension of time to respond to a CRL is reasonable.


FDA expects this guidance will promote efforts to address deficiencies faster, make the process for submitting and reviewing extension requests more efficient and predictable, and allow the agency to focus its resources on ANDA assessment.


CLICK this LINK to know more about the action that USFDA takes when the company Fails to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe.

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