Category: FDA

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…

Emerging data from clinical trials evaluating the use of immune checkpoint inhibitors (ICI) as part of adjuvant, neoadjuvant, and perioperative regimens indicate improved outcomes for patients with resectable non-small cell lung cancer (NSCLC), including early data suggesting a survival benefit. Perioperative treatment encompasses the entire period surrounding surgery, with neoadjuvant therapy administered before surgery and…

Testimony for the hearing noted the recent authorities provided through the Food and Drug Omnibus Reform Act of 2022 (FDORA) designed to enhance the accelerated approval program and ensure timely generation of confirmatory evidence.