ANDA Sybmissions-Refuse-to-Receive Standards: Guidance for Industry.

摘要

This guidance is intended to assist applicants preparing to submit to the Food and Drug Administration (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 FDAs experience have led FDA to refuse-to-receive an ANDA. This guidance also describes how FDA will assess deficiencies identified during FDAs 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. FDAs guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe FDAs current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.