The agreement effectuated by the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA VI) and the first reauthorization of the Biosimilars User Fee Act (BsUFA) substantially alter the fee structures of these programs and provide resources for FDA to carry out significant activities detailed in the letters of agreement between FDA and stakeholders. In this webinar, key stakeholders will describe the PDUFA and BsUFA agreements, highlight major changes, and identify implementation issues to watch. Following panelist presentations, there will be discussion of key issues among the panelists and an opportunity to ask questions.
Kay Holcombe, Senior Vice President, Science Policy, Biotechnology Innovation Organization (BIO)
Lucy Vereshchagina, Vice President, Science & Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA)
Jeff Allen, President and CEO, Friends of Cancer Research (Friends)
Jeffrey K. Francer, Senior Vice President & General Counsel, Association for Accessible Medicines (AAM)
Moderated by Elizabeth Jungman, Director, Public Health Programs, The Pew Charitable Trusts