WebThe Center for Drug Evaluation and Research (CDER) provided a live webcast of the April 21, 2024 meeting of the Oncologic Drugs Advisory Committee. A recording of the … WebFeb 10, 2024 · FDA Opening Remarks Oncologic Drugs Advisory Committee (ODAC) Meeting. February 10, 2024. Harpreet Singh, MD. Director, Division of Oncology 2. Office of Oncologic Diseases

October 17 – 19, 2024: Hearing Announcement involving the …

WebApr 15, 2024 · The FDA also has scheduled an ODAC meeting for April 21, 2024, in which it plans to discuss the appropriate approach for phosphatidylinositol-3-kinase inhibitors under development for treatment of hematologic malignancies. Ukoniq is within this class of drugs and may be discussed during this meeting. WebJan 6, 2024 · More context for the FDA’s new dose optimization scrutiny: Duvelisib is a member of a class of oncology treatments called PI3K inhibitors; a May 2024 ODAC meeting focused on lessons learned about this drug class. A key point from that meeting was the overall inadequacy of dose exploration and optimization for the class, a finding … alamo children\u0027s clinic alamo tx

FDA to Hold ODAC Meeting for Recently Withdrawn PD-1, PD-L1 …

WebSep 22, 2024 · The US FDA will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to discuss overall survival data from the Nova trial. Oncologic Drugs … WebApr 21, 2024 · The FDA’s Oncologic Drugs Advisory Committee has voted 16 to 0 that future approvals of PI3 kinase (PI3K) inhibitors be supported by randomized data given … WebMay 12, 2024 · The fall ODAC meeting is being held September 22-23, 2024. ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products ... alamo choice line