WebFeb 9, 2024 · The white paper suggests the accelerated approval pathway should be revised to make the process of withdrawing an accelerated approval drug easier. “We recognize that there could be multiple factors that lead a confirmatory trial to fail. One reason is the drug has no effect. WebOct 7, 2024 · This website uses cookies to deliver to you the best experience possible on SITC CONNECT. By continuing to use this site, you are providing to us your consent to ensure you receive such an experience.
Watch Now: “Beyond Breakthrough: Optimizing the Breakthrough …
WebMay 5, 2024 · The FOCR white paper includes a figure on types of study designs for screening tests that incorporate real-world data. For example, RWD could serve as an external control arm, a case-control study, or a cohort study. WebDec 20, 2024 · One assessment cited in a new white paper from the Friends of Cancer Research (FOCR) found that therapies approved through this accelerated pathway became available a median of 3.4 years earlier than would be achievable through the traditional FDA approval pathway. phone with spin dial
Rethinking the Accelerated Approval Pathway at the FDA
Web1800 M Street NW, Suite 1050 South, Washington, DC 20036 Phone: (202) 944-6700. Friends of Cancer Research is a 501 (C)(3) non-profit organization. WebDec 20, 2024 · Fostering a Safe and Healthy Work Environment through Competency-Informed Staffing Psychological Safety and Learner Engagement: A Conversation with Dr. Kate Morse Innovation and Solutions to Challenges in Nursing Education More... Podcast Library Journals & Articles Podcast Library WebThe objectives of this white paper are to assess the current state of ctDNA as a monitoring tool used to evaluate clinical response through the description of relevant case studies, … how do you spell peter pan