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USFDA Guidance: Failure to Respond to an ANDA Complete Response Letter

Yesterday (14-December-2022), USFDA published the revised final guidanceFailure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe".

A Complete Response Letter (CRL), is a regulatory action (letter) by the Food and Drug Administration in response to a New Drug Application, Amended New Drug Application, or Biologics License Application, indicating that the application will not be approved in its present form.

In this guidance, FDA provides information and recommendations on how an applicant may proceed after the issuance of a complete response letter (CRL) about abbreviated new drug applications (ANDAs), as well as what action the FDA may take if an applicant does not respond.

Additionally, this guidance identifies the information that applicants may submit along with a non-exhaustive list of factors that the FDA generally intends to consider when determining whether an extension request is reasonable.

After receiving a CRL, under FDA’s regulations, an applicant must

  1. resubmit its ANDA (i.e., submit all materials needed to fully address all deficiencies identified in the CRL),

  2. withdraw its ANDA, or

  3. request the opportunity for a hearing.

An applicant who fails to address all deficiencies listed in the CRL within one year of receiving the CRL may be asked to withdraw the ANDA unless an extension of time is requested.

Click this LINK to know more about the Submission & evaluation of a Request for an Extension to Respond to a CRL, etc.


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