Search Results for keywords:"FDA Workshop"

The Food and Drug Administration (FDA) is hosting a workshop titled "Best Practices for Development and Application of Disease Progression Models," which is part of their performance commitment under the Prescription Drug User Fee Act of 2017. The workshop aims to discuss the best practices for creating disease progression models that can aid in drug development, and to explore current challenges and research needs in this area. The FDA is inviting the public to submit comments about areas of interest related to disease progression modeling to ensure a comprehensive discussion during the workshop. Comments must be submitted by March 26, 2021, and can be sent electronically or through written/paper submissions.

The Food and Drug Administration (FDA) is organizing a public workshop titled "FY 2025 Generic Drug Science and Research Initiatives Workshop" to discuss science and research initiatives for generic drugs. The workshop will take place on June 3 and 4, 2025, at the FDA White Oak Campus in Silver Spring, MD, and will also be accessible virtually. The FDA seeks input from various interested groups, including industry professionals and patient advocates, as part of their ongoing commitment to develop annual science initiatives under the Generic Drug User Fee Amendments (GDUFA). Attendees can submit electronic or written comments about the workshop until July 7, 2025.