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  1. Generic Drug User Fee Amendments

Transcript: Review Status Update

Hello, my name is Dawn Kimble-Vance and I’m a Regulatory Project Manager, also known as an RPM, with the Food and Drug Administration in the Office of Generic Drugs.  I work in the Division of Project Management and my background is a Pharmacist and Nurse and I have 20 plus years of industry experience. 

RPMs manage the coordination of the multi-discipline reviews and are also your primary contact for your abbreviated new drug application which I will refer to as an ANDA.

RPMs also field phone calls about ANDA Review Status Updates, and I’ll be sharing this part of the program under the Generic Drug User Fee Amendments of 2017 also known as GDUFA II.

Before we talk about the details of what is new, let's start with the GDUFA II commitment letter which provides that: "The Authorized Representative may periodically request a Review Status Update. In response to the Authorized Representative's request, the RPM will timely provide a Review Status Update".   Review status updates have now been formally added to the GDUFA II Program. 

This process was not part of GDUFA I,  and as a courtesy, RPMs moved from providing a response, such as call back in 3 months, to providing status updates for all review disciplines.  Although this was a courtesy to applicants, we saw that these review status updates were very important to applicants for planning purposes, and our goal is to provide great customer service.  Therefore, review status updates were added to the GDUFA II Program. RPMs also track communications with applicants.

What does this mean? Now that status updates are part of the GDUFA II Commitment Letter, we have revised FDA's Manual of Policy and Procedures, or MAPP 5200.3, Communications with Industry with Respect to Abbreviated New Drug Applications. 
The impact to each of us is now we have an organized process for an applicant to receive a review status update.

Who is responsible to do what for Status Updates? For the applicant, the authorized representative should be listed on Form FDA 356h.  If they are not listed on Form FDA 356h and request a review status update via email, the RPM will respond only if the requestor has an email address with the company email extension.  If a status update is requested via a phone call and the requestor is not listed on Form FDA 356h, an email will be sent to the person listed on Form FDA 356h. 

You may ask why you won't receive a returned phone call if the requestor is not listed on Form FDA 356h.  At the FDA, we respect that each ANDA is confidential for each applicant and therefore need to ensure that confidentiality is maintained. 

A phone call could come from anyone, so the best way to ensure the RPM is speaking with an authorized representative or company employee is to email or speak with the person listed on Form FDA 356h.  When a RPM receives a request for a review status update, they will strive to provide a response within two business days.

After your Filing Acknowledgement letter is issued, you will receive an introductory call from the RPM that has been assigned to the ANDA. The RPM will be your primary point of contact for your ANDA.  During the review cycle, the RPM will contact you 3-5 additional times. These times will be during a review, notifying you of an upcoming action letter and just after an action letter is endorsed before the Goal Date.

Other times that you will be contacted by the RPM include: in response to a review status update request, if we anticipate we will miss a Goal Date, if a MAJOR deficiency is expected to be issued, and acknowledgement letters.

RPMs will keep track of all communications with applicants, both incoming and outgoing.  We will periodically evaluate review status update requests to ensure that these requests add value to the ANDA review process and do not prevent the RPMs from managing their workload. 

What can you do to assist with the review status update process?  Note the RPM touchpoints where you will be contacted regarding your ANDA without the submission of a review status update. If there are status update needs by your company outside of the touchpoints discussed previously, please contact your RPM.  We do ask that these contacts are not excessive.  This will allow the RPM to effectively manage your ANDA as well as other ANDAs that they manage.

For additional information regarding the review status update process, please see FDA's MAPP 5200.3, Communications with Industry with respect to Abbreviated New Drug Applications.   If you require a review status update or have another request and your assigned RPM is out of the office, please reach out to the covering RPM.  As RPMs we leave a contact email to help with requests.  If the covering RPM is not available, you can reach out to your assigned RPMs Team Leader.   Thank you.

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