From DCAT Value Chain Insights (VCI)
The US Food and Drug Administration (FDA) has issued final guidance, ANDA Submissions–Refuse-to-Receive Standards: Guidance for Industry, to assist applicants preparing to submit to the 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 the 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.
The 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, the guidance identifies certain deficiencies and certain recurrent deficiencies that in FDA’s experience have led FDA to refuse-to-receive an ANDA. The guidance also describes how the FDA will assess deficiencies identified during FDA’s filing review to determine whether an ANDA should be received. The FDA notes in its guidance that the industry is aware of many of the standards described in this guidance because the FDA has historically applied many of these standards in its refuse-to-receive determinations.
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