FDA publishes two revised final guidances for industry to reflect passage of GDUFA II and publishes one new MAPP

On October 4, 2017, the U.S. Food and Drug Administration (FDA) published updates to two final guidances for industry. The following guidances now reflect GDUFA II commitments and performance goals:  

• ANDA Submissions – Prior Approval Supplements Under GDUFAThis guidance is intended to assist applicants preparing to submit to FDA prior approval supplements (PASs) and amendments to PASs for abbreviated new drug applications (ANDAs). This final guidance has been revised to reflect the new performance review goals as they relate to the review of PASs. Specifically, this guidance describes how the GDUFA II performance review goals apply to standard and priority PASs that require an inspection, standard and priority PASs for which an inspection is not required and amendments to standard and priority PASs.

• Completeness Assessments for Type II API DMFs Under GDUFAThis guidance is intended for holders of Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are or will be referenced in an abbreviated new drug application (ANDA), an amendment to an ANDA, a prior approval supplement (PAS) to an ANDA, or an amendment to a PAS. This final guidance has been revised to reflect the new GDUFA II performance review goals for conducting completeness assessments. In accordance with GDUFA II, FDA committed to complete the initial completeness assessment review for 90% of Type II API DMFs within 60 days of the later of the date of DMF submission or DMF fee payment.

In addition, the FDA published a new section of the Manual of Policies and Procedures (MAPP 5220.1), “Receiving and Processing a Request for Voluntary Withdrawal of an Approved ANDA.” This MAPP outlines the policies and procedures for receipt, review, and processing of a withdrawal request submitted by a holder of an approved abbreviated new drug application (ANDA) to the Office of Generic Drugs (OGD). This MAPP applies to the Regulatory Project Managers (RPMs) in OGD who receive and process requests for withdrawal of ANDAs pursuant to 21 CFR 314.150(c). An ANDA remains in an “approved” status in FDA’s electronic regulatory tracking systems until a notice is published in the Federal Register (FR) stating that the ANDA is withdrawn. Once an approved application is effectively withdrawn (the “effective date” as identified in the notice published in the FR occurs), the ANDA holder is no longer subject to the legal and regulatory requirements for maintaining an approved ANDA. The OGD RPM will process a voluntary request for withdrawal and any rescission of a request for voluntary withdrawal that has not become effective in accordance with the procedures outlined in the MAPP.