The Office of Generic Drugs’ update to the Activities Report of the Generic Drug Program for June 2017 (here) lists 6 Refuse-to-Receive (RTR) actions, the lowest for any moth this fiscal year. As a matter of fact, it is the lowest number of RTR actions since early in the GDUFA days when, in May 2013, there were 2 RTRs and, before that, December 2013 when there were 4 RTRs. Below is a table of average monthly RTR actions for the five years of GDUFA, albeit only 9 months data are available for 2017.
|Fiscal Year||Monthly Avg. RTR Actions|
- Thru June 2017
This appears to be good news for OGD and the pharmaceutical industry as, thus far, in year 5 of GDUFA the rate of RTR actions is the lowest since the inception of the program. This may also mean that the industry has a better understanding of the requirements and/or OGD is working more closely with applicants to resolve minor RTR issues during the initial filing review.
The number of Controlled Correspondence (CC) submitted by industry reached a high for FY 2017 in June at 286. There appears to be still a lot of questions from the industry and, because there are GDUFA goal dates for CC responses to these questions, this places a drain on OGD resources. Perhaps OGD might want to consider publishing responses to general questions so that there might not be as many repeats. Just a thought.
Changes Being Effected supplements are still over 500 for June 2017 (532) and Prior Approval Supplements are close to the average at 40 for June. A high of 30 ANDAs were withdrawn during the month and 62 DMF completeness assessments were conducted.
The June update can be found here. We love to keep you updated on activity at OGD and hope you enjoy seeing these reports.