Report: Office of Generic Drugs pledges to take action on ANDA backlog

WASHINGTON — In a staff memo, the Office of Generics Drug’s acting director, Kathleen Uhl, vowed to take action on 90% of the abbreviated new drug application backlog before October 2017, and has appointed Ted Sherwood as acting director of OGD’s Office of Regulatory Operations to help with the improvements, FDANews.com has reported.



“To get to a steady state, we will focus on approvals not actions, and make other business process improvements, to improve our productivity and communications with respect to the pre-Year 3 workload,” Uhl stated in the memo. Uhl noted that additional details will be coming in the next few weeks.



According to the report, generics makers have worried that the Food and Drug Administration sees its GDUFA commitments only as issuing complete response letters to satisfy performance goals under the law.



At its peak, nearly 3,000 ANDAs sat on backlog, which consists of ANDAs filed before GDUFA established performance goals that went into effect Oct. 1, 2014, according to the report.