If you have been reading my blog regularly, I guess I have gotten much of the reading of the wind correct because there was not a lot of new information in Cook’s (Kathleen Uhl M.D., Director, Office of Generic Drugs) talk at this year’s Association of Accessible Medicines (AAM) Fall Technical Conference in Bethesda, MD.  However, there were some statistics reported that verify some of our assumptions and a few new looks at the data.

One that I thought was particularly interesting was the data on the impact of refuse-to-receive (RTR) on the review cycles.  It is clear that an RTR-ed application has a much less chance of getting approved in the first cycle and will have more review cycles associated with it than an application that is received straight away. (see chart below) In addition, FDA notes that if the resubmission is hurried FDA sees lots more deficiencies.  The message here, fix it right before resubmitting.

Another interesting point in Cook’s presentation was a review of first cycle approvals for the specific cohort years.  We looked at the September 2017 approvals and tried to calculate a back-of-the-envelope first cycle approval rate and came up with about an 11% mixed rate for all of the ANDAs approved or tentatively approved in that month.  Not bad, eh!


Cook also spoke about problems with “hidden facilities” in the applications.  These are facilities that are not clearly identified on the 365h form, and when discovered by OGD, their existence derails the review of the ANDA.  Cook also noted that controlled correspondence submissions are soaring and often are more complex with >8000 submitted during the 5-year GDUFA I period.

We will be back with more from the AAM Fall Technical coverage during the week.