Public Meetings

FDA periodically holds public meetings to get stakeholder input. Three major Prescription Drug User Fee Act (PDUFA) public meetings were held for PDUFA IV. The purpose of the November 2005 public meeting was to hear stakeholder views as FDA prepared to work on reauthorizing legislation for PDUFA IV. FDA's PDUFA IV proposals, which were negotiated with industry, were presented to the public at the February 2007 public meeting for comment before being submitted to the Congress. The October 2007 public meeting provided stakeholders the opportunity to address specific topics and present their views as FDA prepared the PDUFA IV IT Plan. Agendas and other meeting materials are provided.