Thank you for your interest in the GDUFA II Program.  My name is Ted Sherwood and I am with the Office of Regulatory Operations, Office of Generic Drugs.  This presentation is designed to show how the new goal structure, review classification process, information requests, discipline review letters and mid-review-cycle teleconferences are operationalized. 

There are a few new and changed features with GDUFA II. The review time for priority ANDAs with a successful Pre-submission Facility Correspondence is now 8 months.  The definition of priority is tied to the ANDA Prioritization MAPP.

Mid-point communications are formalized through Information Requests and Discipline Review Letters. To begin, FDA will use Discipline Review Letters to communicate the preliminary thoughts of the primary reviewer at the mid-point of the cycle.  Other requests from the review team may be issued through Information Requests. Also, for those applications that successfully participated in a meeting as part of the Pre-ANDA program, there is an opportunity for a mid-review-cycle teleconference with the review staff members to discuss the current status of the application.

This means that there are now formally shorter goals for priority products submitted in an ANDA that links to a Pre-submission Facility Correspondence. There will also be more communications for all applicants during the original goal period.

The process starts when an application is received by the Office of Generic Drugs.

There is a formal filing period and OGD aspires to complete its assessments and communicate filing decisions within 60 days for a majority of the applications. The Filing Decision sets the goal date. It is best to work backwards through the process as the goal date determines the Mid-point. The mid-point sets the mid-point plus 1 month period.

The GDUFA goal date becomes the base of the operational dates. The goal date sets the date for the issuance of the mid-cycle Discipline Review Letter, and when appropriate, the mid-review-cycle teleconference.

To hit these mid-cycle dates, a mid-review date has been created to turn the reviews over to the appropriate discipline project managers and Regulatory Business Project Managers in the Office of Pharmaceutical Quality to prepare the Discipline Review Letter. Discipline Review Dates were created to help reviewers manage their work and facilitate meeting the dues dates.

The Discipline Review Date completes review phase 1. During review phase 1, consults will be identified and issued, as appropriate. That means that many disciplines will use a triage process to identify consults and missing information.

Missing information may be communicated to applicants through the use of Information Requests during the review phases, but only after the application has been acknowledged by the Division of Filing Review. The responses to information requests and the discipline review letters will be submitted to the application as amendments.

The complete response to the Discipline Review Letter will trigger the next review phase which ends in time to meet the goal date.  Exceptions will be allowed in cases where an imminent approval can be reached shortly after the goal date. Again, we will use the Discipline Review Date to line up the review team for successfully completing their work in time for the project managers to prepare the action letter.

All of this is review phase 2.  Depending on the timing of reviews and responses from applicants, additional phases could occur within the goal period.  

Here is how the process looks when a Pre-submission Facility Correspondence is utilized in advance of a priority submission.  The PFC will be submitted in advance of the application and the facilities results will be incorporated into the appropriate discipline’s final decision.

There is greater business certainty for applicants as the review times are formalized for all applications and there are more review communications. This also allows applicants that submit a quality application to make minor updates and gain a 1st cycle approval or tentative approval.  This is a big win for both FDA and the firm!

Applicants desiring an 8 month goal for a priority application must submit a successful Pre-Submission Facility Correspondence.  The applicant must justify the priority in both its formal ANDA submission and now the PFC, and of course submit an application that meets and hopefully exceeds the filing criteria. The Division of Filing Review will set the goal for ANDAs that are received for further review. 

In setting the review goal date, the Division of Filing Review will assess applications requesting a priority designation to determine if the drug product warrants a priority and the Pre-Submission Facility Correspondence was found adequate by both the Office of Pharmaceutical Quality and the Office of Translational Sciences.  Further, the information previously submitted in the PFC must be unchanged in the ANDA.  The application will receive the same type of filing review as it did under GDUFA I.

Prioritization requests undergo an independent, secondary validation.  OGD can calibrate the accuracy of our decisions off of that.  Further, there will be increased tracking and reporting functionality for priority applications in the Platform and watch for more public posting of the generic drug program’s success.

Industry plays a role in the success of GDFUA II.  Carefully tell the story of your application.  That starts with complete and clear Pre-submission Facility Correspondences, which are essential to applications receiving the priority 8 month goal. 

Applicants should use the Prioritization MAPP to justify the submission of a PFC and priority goal being requested for their application. Applications linked to a PFC should clearly highlight that linkage in the cover letter.

Another key for applicants is providing complete and quick responses to IRs and DRLs.  This helps the Agency move the application towards approval within the cycle.

It is also essential for applicants to champion their own ANDA.  By this we mean that applicants should utilize good contractors and stay in communication with those contractors.  Applicants should carefully consider the timing of non-essential changes and those being considered by their contractors.  Submission of a change prior to a goal date is often very disruptive to the review process and subsequent timing of the action letter.  Many approvals have been delayed due to late submissions from contractors.

There are several documents related to the application review process and the related goals.  Watch for more.

The best source of information about the goals related to a specific application is your Regulatory Project Manager. The best source of information about Information Requests and Discipline Review Letters is the Discipline Project Manager. Thank you for your interest in the GDUFA II Goals Integration.