Speaking at the Pre-Meeting Project Manager Workshop, OGD staff reminded participants of the fact that in year 1 and 2 of GDUFA, there are no real metrics, and reviewed the GDUFA goals for years 3-5 of the five year program.

Along with this reminder,  OGD GDUFA Implementation Team Member Christina Kirby noted that all amendment goals are incremental, meaning that pre-FDA Action Amendments results in an adjustment of goal date and  post-FDA Action Letter submissions sets a new goal date.  She went on to discuss the Tier 1-3 amendments and the implications of each relative to the impact on the GDUFA goal date.

The bottom line for Industry is to be careful when submitting amendments because your expectations of a specific approval or review date may be dashed.

Bob Pollock also pointed out to be particularly careful when amending a Tentatively Approved ANDA to approval status to assure that only the administrative information required for the change to full approval is provided to FDA.  Making any CMC changes would result in a resetting of the review clock for review.  So, unlike in the old days, when additional information was learned (perhaps in your validation efforts to optimize the process, for example) and that information was submitted with the request for final approval, that information was reviewed and the approval was not delayed; however, now under GDUFA, that new information would result in a resetting of the review clock, with up to a 10 or 12 month goal date.  Not a good thing for a product you thought was going to be approved quickly.

Learn the ins and outs of the GDUFA metrics and time penalties that may be associated with your submissions.  While this is not new, the regulations have always given OGD the right to extend review times for amendments for the length of time it would take to review the amendment, OGD chose not to enforce that provision. Now under GDUFA they have no choice!