The Food and Drug Administration's Accelerated Approval Process — A Workshop

The project aims to examine the current regulatory framework for the Food and Drug Administration's accelerated approval pathway and identify ways to strengthen it. The project will convene a two-day multistakeholder virtual workshop to assess the accelerated approval authority and explore ways to strengthen the process. Potential participants include federal and state government public health officials, U.S. and other national regulatory authorities, congressional staff, academia, the legal community, industry, patient advocacy groups, and members of the public. Exact topics will be decided in conjunction with Fund staff and the other funders but could consist of the regulatory framework of the accelerated approval process, the validity of surrogacy endpoints, postapproval confirmatory trials, price limitation, the interaction with payer coverage and reimbursement decisions, and international lessons.