FDA: ANDA Submissions – Refuse-to-Receive Standards

This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) to ANDAs for which the applicant is seeking approval of a new strength of the drug product. The guidance highlights deficiencies that may cause FDA to refuse to receive an ANDA. A refuse-to-receive decision indicates that FDA determined that an ANDA is not sufficiently complete to permit a substantive review. This guidance is not meant to be a comprehensive list of the deficiencies that may or will lead to a refuse-to-receive determination by FDA. Instead, this guidance identifies certain deficiencies and certain recurrent deficiencies that in FDA’s experience have led FDA to refuse-to-receive an ANDA. This guidance also describes how FDA will assess deficiencies identified during FDA’s filing review to determine whether an ANDA should be received. We note that industry is aware of many of the standards described in this guidance because FDA has historically applied many of these standards in its refuse-to-receive determinations.