This guidance is intended to assist applicants of abbreviated new drug applications (ANDAs), which were submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)), in responding to complete response letters (CRLs) from FDA.
This guidance provides information and recommendations regarding potential courses of action for an ANDA applicant after issuance of a CRL, as well as the actions that FDA may take if the applicant fails to respond to that CRL.
As described in regulation, ANDA applicants are required to take action after receiving a CRL. The guidance revises the guidance of the same title issued in July 2022.
This revision is being issued to incorporate the performance goals outlined in the Generic Drug User Fee Amendments Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III commitment letter).
FDA’s regulations provide that if an applicant wishes to continue pursuing approval of its ANDA, an applicant should submit all materials needed to fully address all deficiencies identified in the CRL (Complete Response Letter) within 1 year of issuance of the CRL.
If an applicant wishes to continue to seek approval in this manner and determines it will be unable to address the deficiencies within 1 year of issuance of the CRL, the applicant should submit an amendment to its ANDA requesting an extension of time to address those deficiencies.
The applicant should submit its request for an extension on or before the date the response to the CRL is due.
If an applicant fails to submit to FDA all materials needed to fully address all deficiencies identified in the CRL within 1 year after issuance of the CRL (or take either of the other two actions prescribed by regulation and that are described above), FDA may consider this failure to be a request by the applicant to withdraw the ANDA. FDA will notify the applicant in writing and the applicant will have 30 days from the date of that notification to -
(1) explain why the ANDA should not be withdrawn and
(2) request an extension of time to address all deficiencies identified in the CRL.
This guidance cover the following topics -
- Failure to Respond to a CRL Within 1 Year
- Failure to Respond to a CRL Within the Extended Time Period Granted by FDA
- Submission of a Request for an Extension to Respond to a CRL
- Evaluation of a Request for an Extension to Respond to a CRL
- Withdrawal of an ANDA
