The FDA released a guidance to remain in effect until the COVID-19 public health emergency is resolved titled Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications — Questions and Answers ( here). In this guidance, the Agency addresses many questions they have been asked about scheduling meetings, face-to-face (FTF) meetings, or reviews of NDAs, BLAs, ANDAs, and the associated goal dates.
In general, the Agency has indicated that most scheduled or requested meetings will be converted to either teleconferences or virtual video meetings. As far as user fee dates are concerned, the Agency explains that they will try to meet PDUFA, BSUFA, and GDUFA goal dates, but due to deployment of some of the Commissioned Corps officers and other FDA resources which have been redirected to COVID-19 related activities, it may not be possible to meet all user fee goal dates. The document addresses how the Agency will communicate missed dates to applicants and the appropriate contact persons that the applicants can reach out to when addressing missed goal dates.
As the FDA wrestles with COVID-19-related issues, they acknowledge that they may not be able to keep up with routine (non-COVID-19) work indefinitely, but they will do their best under the circumstances. Please read the guidance for additional details.
