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  1. Generic Drug User Fee Amendments

Pre-submission of Facility Information under the Generic Drug User Fee Amendments of 2017 (GDUFA II)

FDA has issued a revised draft guidance for industry entitled, ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) .  This guidance revises a previous draft issued in June 2017, and provides a more streamlined process based on the new statutory authority provided under Section 801 of the FDA Reauthorization Act of 2017 (FDARA). 

The revised draft guidance describes the process through which generic drug applicants pre-submit complete, accurate facility information in advance of a priority abbreviated new drug application (ANDA), prior approval supplement (PAS), or amendment under the Generic Drug User Fee Amendments of 2017 (GDUFA II).  In order to be eligible for a priority review goal, the application must meet the criteria listed in Section 505(j)(11)(A) of the Federal Food, Drug, and Cosmetic Act or the criteria listed in the Center from Drug Evaluation and Research’s (CDER) Manual of Policies and Procedures (MAPP) 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements.  In addition, the content of the pre-submission must meet the requirements listed in Section 505(j)(11)(B) of the Federal Food, Drug, and Cosmetic Act.  One of the key requirements of this section is that pre-submitted facility information must be unchanged relative to the application submission date.

FDARA significantly simplifies the process of preparing and submitting pre-submission facility information from that which was described in the earlier version of the guidance.  The earlier version recommended that the applicant provide facility information to FDA in a new type of document, described in that draft guidance, and resubmit essentially the same information in the form of relevant eCTD sections of the application when the application was submitted.  The statute improved this process by stating that the pre-submission will include sections of the application.  As a result, the FDA can designate the relevant sections of the application by their respective eCTD modules, and this information can be submitted in the usual way, at least 60 days before submission of the rest of the application.

FDARA’s provisions require the FDA to determine the relevant sections of an application to be provided in a pre-submission of facility information.  Accordingly, the revised draft guidance lists the sections of the application containing facility information that the FDA will review to determine whether inspections will be necessary for the facilities identified in the pre-submission.  All the facility information listed in the revised draft guidance is information the FDA typically considers during the early stages of review when determining whether inspections are needed for manufacturing facilities and bioequivalence and clinical testing sites and organizations.

Applicants are encouraged to pre-submit facility information using the recommendations in the newly revised draft guidance.  However, we recognize that some applicants may have already started preparing a pre-submission following the recommendations of the original draft guidance.  To accommodate these applicants during this period of transition, FDA will accept pre-submissions that follow either version of the draft guidance until December 6, 2017.   Firms with specific questions about pre-submitting facility information related to prioritized generic drug applications can email PFC-Inquiries@fda.hhs.gov.   

The FDA established a public docket for comments on the original draft guidance.  The revised draft guidance has the same public docket number (Docket No. FDA-2017-D-3101).  Because the public docket number has not changed since the original draft guidance was issued, it is not necessary to resubmit comments already submitted to the docket.  The public may submit comments at any time; however, in order to ensure that the FDA considers them before finalizing the guidance, comments should be submitted within 90 days of the Federal Register notice disclaimer icon of publication of this revised draft guidance.  The FDA will consider all comments submitted to the docket within this timeframe when finalizing this guidance.