Failure To Respond to an Abbreviated New Drug Application Complete Response Letter Within the Regulatory Timeframe; Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Failure To Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe." This guidance is intended to assist applicants in responding to complete response letters (CRLs) to abbreviated new drug applications (ANDAs) submitted to FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act). 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 a CRL. In addition, this guidance recommends information 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 FDA generally intends to consider in determining whether such a request is reasonable. This guidance finalizes the draft guidance of the same title issued on September 29, 2020.