Category: FDA

What was the committee asked to consider? On April 30, 2026, the U.S. Food and Drug Administration (FDA) convened the Oncologic Drugs Advisory Committee (ODAC) to consider the benefits and risks of two regimens for treatment of cancer.    The morning session focused on the results of the SERENA-6 trial, which was intended to support a new…

The U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) hosted a virtual public listening meeting on September 18th. During this meeting, stakeholders from regulatory agencies, patient advocacy organizations, industry, and academia convened to discuss how prior knowledge and platform approaches could be better leveraged to…

What was the committee asked to consider?  On July 17, 2025, the U.S. Food and Drug Administration (FDA) convened the Oncologic Drugs Advisory Committee (ODAC) to vote on whether the overall benefit-risk profile of two new combination regimens (belantamab mafodotin + bortezomib + dexamethasone [BVd] and  belantamab mafodotin + pomalidomide + dexamethasone [BPd]) for treatment…

In 2023, the U.S. Food and Drug Administration (FDA) established the Digital Health Advisory Committee (DHAC) to consider topics related to the use of digital tools in drug development. On November 20 and 21st, 2024 the committee convened for the first time to discuss total product lifecycle (TPLC) considerations for generative artificial intelligence (GenAI) enabled medical devices. The establishment of the DHAC and this meeting come in response to growing interest and use of these technologies in healthcare and signal a recognition of the unique regulatory challenges presented by GenAI- and AI-enabled devices.

Friends’ recent research on homologous recombination deficiency (HRD) involved a comparative analysis of 20 independent HRD assays, assessing both an In Silico (n=348; TCGA database) and a Clinical dataset (n=90; nucleic acids from freshly extracted archival ovarian cancer tumor samples). The assays measured a variety of outputs to define DNA damage repair dysfunction and identify patients with high-grade serous ovarian carcinoma (HGSOC) who had HRD. This is important because patients with HRD may benefit from DNA damage repair inhibitor treatments like Poly ADP-ribose Polymerase Inhibitors (PARPi).

Chevron deference was established by the 1984 Supreme Court of the United States (SCOTUS) case of Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc., which related to EPA’s ability to regulate air quality under the Clean Air Act. The decision mandated that federal courts defer to federal agency’s reasonable interpretation of ambiguous statutes…

Chevron deference was established by the 1984 Supreme Court of the United States (SCOTUS) case of Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc., which related to EPA’s ability to regulate air quality under the Clean Air Act. The decision mandated that federal courts defer to federal agency’s reasonable interpretation of ambiguous statutes…