Welcome to GDUFA II Goals training. My name is Vince Sansone, and I’m the Acting Deputy Director of the Office of Regulatory Operations in the Office of Generic Drugs. I’m going to take you through the performance goal dates associated with the reauthorization of the Generic Drug User Fee Amendments or GDUFA II -- as they are stated in the GDUFA II Commitment Letter. We’ll go over how they will affect FDA reviewers’ daily work, industry’s submissions, action dates, and communications between the FDA and industry during review cycles.

To begin, let’s take a look at what is new or changed from GDUFA I. GDUFA II removes tier classification of amendments.  All abbreviated new drug applications or ANDAs received on or after October 1, 2017, will receive a standard or priority designation. And depending on the designation, the appropriate goal dates will be assigned as outlined in the GDUFA II Commitment Letter.  In GDUFA II, FDA is committed to meeting goal dates for 90% of all ANDA original, amendment, and prior approval supplements submissions. 

This slide depicts the 90% goal metric applied to originals and amendments, and how the potential goal dates are calculated based on certain criteria. For example, priority vs. standard and if a Pre-Submission Facility Correspondence was submitted.  Let’s consider a possible scenario. A major amendment with priority status could receive a goal date as short as 6 months if a pre-approval inspection is not required.

 

This table follows the same logic as the previous slide but with regards to Prior Approval Supplements and their amendments.

The impact of these GDUFA II changes is twofold.  One - applicants have opportunities to receive shorter goal dates under certain conditions and two - there are more predictable dates or timelines for ANDA actions and communications during review cycles.

In GDUFA II, both the FDA and ANDA applicant have distinct responsibilities and roles. The applicant is responsible for submitting ANDAs, amendments, and supplements with required information, such as a complete and accurate Form FDA 356h.  For applicants who desire consideration for priority designation, the request should be formally submitted, and the reason for requesting priority designation should be clearly cited, as outlined in MAPP 5240.3. The FDA determines submission goal dates for original ANDAs. 

The Division of Filing Review determines the goal date when an application is filed based on receipt date, priority designation, and submission of a substantially complete application.  For ANDA amendments, the regulatory project manager determines the goal date based on receipt date, major vs. minor, priority designation, and need for inspection.

For Prior Approval Supplements, the regulatory project manager from the Office of Generic Drugs, regulatory business process manager from the Office of Pharmaceutical Quality, or labeling project manager from the Office of Generic Drugs determines the goal date based on receipt date, priority designation, and need for inspection.

For submissions that require inspection, the goal date may be affected by whether the applicant submitted a complete and accurate pre-submission facility correspondence (or PFC) that remains unchanged at the time of the ANDA submission.

How will Success be measured? Success will be measured against the 90% metric from the GDUFA II Commitment Letter for each of the categories listed on this slide: ANDA originals; ANDA amendments; Prior Approval Supplements, and Prior Approval Supplement amendments.  FDA will make every effort to either meet or exceed the 90% metric outlined in the GDUFA II Commitment Letter.

What can Industry do to assist?  Generic Drug Applicants can promote success by submitting clear and complete applications. For example, ensure that each submission contains a complete and accurate Form FDA356h.

Requests for priority designation should be noted on the submission cover letter and contain the information requested in MAPP 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements. Also, cover letters, as applicable, should reference any Pre-Submission Facility Correspondence, or PFC, the date the PFC was submitted, and the date of FDA’s acknowledgement letter indicating the PFC’s eligibility for further assessment. 

We recommend submitting a stand-alone certification statement in your submission confirming that the facility information initially submitted in the PFC has not changed with the ANDA submission.  We recommend that any and all differences between the facility information submitted in the ANDA versus the PFC, be identified in the recommended stand-alone certification statement.  This assists the Division of Filing Review project managers and the regulatory project managers in triaging the submission more efficiently and accurately.

The goal date tables provided earlier in the presentation are straight from the GDUFA II Commitment Letter.  The commitment letter is the primary resource for operationalizing GDUFA II goal date setting. Here are additional resources that applicants and FDA personnel can reference for additional questions:  the GDUFA II Commitment Letter, which defines how goal dates are established; the Amendments Guidance, which provides applicants with the proper procedures of ANDA amendment submission, and the Prioritization MAPP, which outlines the criteria for what defines a priority submission.

Please remember that the primary point of contact post-Filing is the Regulatory Project Manager regarding Original A.N.D.A. submissions and their amendments.  For Prior Approval Supplements, the primary contact will be dependent upon on the disciplines involved. Labeling PASs will be the Labeling PM; Quality PASs will be the RBPM; and PASs with two or more disciplines will be the RPM.  Thank you for your time.