Hello. My name is Erin Skoda, and I'm a Quality Assessment Lead in the Division of Lifecycle API. I will walk you through the new features of GDUFA II related to Type II Drug Master Files - or DMFs -- for Active Pharmaceutical Ingredients outlined in the GDUFA II commitment letter.     

My goal for this presentation is that you will be aware of and understand the new features related to Type II DMFs.   These features fall under the broad categories of Performance Goals and Review Program Enhancements. We'll start by discussing the performance goals.

FDA has committed to a new performance goal for the completeness assessments performed on Type II DMFs that are referenced in abbreviated new drug applications --or A.N.D.A.s). 

FDA has committed to completing 90% of the initial Completeness Assessment reviews within 60 days. And the 60 day clock starts from the date of the DMF submission or DMF fee payment, whichever is later. 

In cases where the DMF fee was paid using a pre-assigned DMF number, the 60-day clock will start when the DMF documents are received by the Agency and the DMF status is set to active.

In order to prepare for GDUFA II, we moved the Completeness Assessment review process to the CDER Informatics Platform, or the Platform, for short. This change has improved the tracking capability of our completeness assessment review process and helps in meeting our timelines. As a result, industry will know when to expect their initial completeness assessment to be finished.

We recommend that the DMF holder starts the Completeness Assessment process at least 6 months in advance of the anticipated submission of a referencing A.N.D.A. This will allow ample time for the DMF to pass the Completeness Assessment even if more than one Completeness Assessment review cycle is needed.

In addition to the performance goals, GDUFA II adds several Review Program Enhancements, which are designed to improve the DMF review process and communication with industry. 

These enhancements cover timing of the comments to the DMF holder during the review process, making teleconferences more user friendly, enhancing communications with a DMF holder regarding the review status of their DMF, and providing additional guidance on post-approval changes to DMFs so A.N.D.A. and DMF holders have a clear understanding of FDA's expectations for reporting changes. 

The goal of these new features is to improve communication between FDA and Industry.

We'll start with the communication of review comments to DMF holders. FDA will ensure that DMF review comments are issued at least in parallel to those review comments relating to the DMF for the A.N.D.A. This commitment applies to comments issued through an A.N.D.A. Complete Response Letter and the first Information Request letter the applicant receives from the drug product review discipline. This will keep the DMF and A.N.D.A. review processes synchronized as much as possible. Timely responses to the DMF deficiency comments will help keep the DMF review aligned with the A.N.D.A. review, a. And response within 30 days is ideal. To aid in this process, DMFs were fully migrated into the Platform in November 2016 so that DMF reviews may be managed and tracked as discipline reviews.

Teleconferences to answer questions regarding comments received in first cycle deficiency letters continue with some minor changes. In order to provide ample time to evaluate the comments and formulate questions, industry now has 20 business days from issuance of the first cycle deficiency letter to request a teleconference. 

The Agency will strive to grant or deny the teleconference within 30 calendar days from the date the request is received. Also, DMF holders now have the option to submit requests for an email exchange between the Agency and the holder in lieu of the teleconference. 

After the FDA responds to the email exchange request, the DMF holder may submit ONE follow-up email for additional clarification.

Both teleconference and email exchange requests should contain specific questions about the Deficiency Letter.   DMF holders should follow the detailed instructions provided in the Complete Response Letter that explains how to request an initial or follow-up email exchange. 

Requests for an email exchange should be sent to DMFOGD@fda.hhs.gov.

The No Further Comments Letters are issued in GDUFA II as they were in GDUFA I. 

The process for these letters was moved into the Platform to be fully integrated with the DMF review process. No Further Comments Letters provide ongoing status updates to the DMF holder throughout the lifecycle of the DMF when a referencing application is approved or tentatively approved. The only change to the No Further Comments Letter process is that the letter will be sent via email when the DMF holder or its agent has a secure email address. 

If you do not have a secure email address, you may obtain one by contacting SecureEmail@fda.hhs.gov.

In order to provide more open and timely communication with industry, FDA committed to issuing a new letter called the DMF First Adequate letter. This letter communicates the important milestone in the DMF lifecycle when the DMF is deemed adequate to support an application for the first time. 

While the content of this letter is similar to the No Further Comments Letter that industry received in GDUFA I, the timing of this letter is different. The First Adequate Letter is issued when the review finding the DMF adequate for the first time is completed. This will thus provide a more timely status update to the DMF holder than the No Further Comments Letter, which only issues at the time of A.N.D.A. approval or tentative approval, which can occur much later than the actual DMF review. 

It is the Agency's hope that a more timely status notification to the DMF holder might foster better communication between the DMF holder and the A.N.D.A. applicant and help prevent poorly timed unsolicited updates to an already adequate DMF. The Agency is in the process of drafting a guidance on Post-Approval Changes to Type II API DMFs that will provide recommendations on the appropriate reporting category for post-approval changes for the referencing A.N.D.A. and the documentation requirements for the DMF. Guidance development efforts are currently underway to meet the October 1, 2018 draft issuance date as specified in the commitment letter. 

Additional information on the topics covered in this presentation can be found at the links on this slide. Thank You for watching.