Hahn Signals COVID-19 Could Affect User Fee Goals, Device Talks Put Off

FDA Commissioner Stephen Hahn said Thursday (April 16) the agency continues to meet its user fee commitments but signaled that could change due to staffers focusing on COVID-19, coming as FDA is unable to hold in-person user fee negotiations and has postponed indefinitely its medical device user fee meeting. There have been no updates on meetings for prescription drug, generic drug or biosimilar user fee programs, but ML Strategies Senior Director Aaron Josephson said the agency still has wiggle room...