The Federal Food, Drug, and Cosmetic Act (FD&C Act) directs the Food and Drug Administration (FDA) to hold monthly discussions with representatives of patient and consumer advocacy groups during negotiations with the generic drug industry on reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA) program. FDA held the first stakeholder meeting on October 19, 2015. Meeting minutes will be posted on the FDA Web site approximately 20 business days after each session.
FDA invites representatives of patient and consumer advocacy groups who wish to participate in these monthly discussions to notify the Agency by email to GenericDrugPolicy@fda.hhs.gov. On August 12, 2015, FDA published a Federal Register notice extending the notification and comment period to April 30, 2016. Your email should contain complete contact information, including name, title, affiliation, address, email address, phone number, and notice of any special accommodations required because of a disability.