Dr. Kathleen Uhl (Cook), Director Office of Generic Drugs (OGD), provided an excellent update on OGD’s progress under GDUFA. There were a number of interesting charts that described approvals, receipts and actions that defined what Cook called the “In Box” (what’s coming into OGD) and “Out Box” (productivity or what is going out of OGD). In general, as previously reported in this blog, approvals and actions are up, but some of the numbers reported may look a little different depending on what charts you read and which part of the FDA website you access. Needless to say, the FDA’s IT platform’s complexity may make it hard to always be assured of the accuracy of the numbers and how applications and actions are counted and reported out on various reports. To further this fact, each chart has a disclaimer relative to the numbers (see below). This may also explain why the numbers that this blogger posts may even look a bit different than the numbers that appear in Cook’s presentation. While the numbers may be a bit different, the magnitude of the difference is relatively small. We have discussed the problem with assuring accuracy of the numbers in previous posts.
Here is a look at approvals and tentative approvals being reported by OGD.
Here is a real shocker and goes to the effort that OGD is expending and shows as Dr. Uhl said “there is no filing backlog. Filing reviews of ANDAs are now real time”. Average time for filing determination is reported to be 31 days.
Filing Review
This chart represents OGD approvals by FY back to FY 2002.
Overall, OGD is keeping its productivity at least as well as pre-GDUFA levels while preparing to meet the ever tightening GDUFA goal requirements.
Dr. Uhl noted that the goal is to reduce the number of review cycles and drive ANDA to 1st cycle approval, but in order to do this the applications must be of high quality and the responses to information requests and easily correctible deficiency letter must also be of high quality.
