Featured Evan Knott admitted to American College of Coverage Counsel Knott handles complex insurance recovery and other commercial litigation matters in state and federal courts around the U.S.
Featured Reed Smith named a 2025 ACC Value Champion Firm and client Brookfield Property Development honored for an innovative solution streamlining BPD’s due diligence screening process
3/11/2025 5:48:19 PM Expect HHS Retirements To Be Material By Scot T. Hasselman Many employees at HHS and its 13 operating and staff divisions (e.g., FDA, HHS-OIG, CDC, NIH) are eligible for either early retirement...
1/22/2025 1:33:22 PM FDA's AI Lifecycle & Scientific Information Guidance Documents By Sung Park Cori Goldberg Gerard Stegmaier FDA is pushing out new guidance documents at a pace rarely seen, likely caused by the upcoming change in administration. Today, we are...
12/20/2024 5:13:31 PM What does "healthy" mean? By Sung Park Cori Goldberg FDA Unveils an Updated Definition of “Healthy” Foods On December 19, 2024, the U.S. Food and Drug Administration (FDA) announced a...
10/30/2024 6:38:22 PM Nov. 20-21 FDA Advisory Committee Meeting on Regulating Generative AI-Enabled Medical Devices By Heather Ritch Rocks Developing a GenAI-enabled medical device? Implementing GenAI in a healthcare application? Curious to hear how FDA is thinking about...
9/29/2023 1:22:09 AM Heard on the Street: FDA Reported to Have Granted First Breakthrough Device Designation for a Radiology Triage Tool By Tom Greeson Sung Park On September 13, 2023, a manufacturer of radiology software solutions – Annalise.ai – announced that FDA granted a breakthrough...
3/13/2023 1:54:35 PM FDA unveils major new changes to its mammography quality standards regulations, and mandates reports to patients about their breast density By Tom Greeson On March 10, 2023, the U.S. Food and Drug Administration (FDA) published in the Federal Register a long-awaited final rule to update...
1/4/2023 2:00:00 PM Sesame is now a major food allergen By Cori Goldberg Happy New Year. To ring in 2023, we can now add sesame to the list of allergens, which means new labels; revisiting marketing claims;...
4/12/2022 4:56:43 PM FDA sends open letter to health care providers regarding use of AI imaging software designed to speed prioritization of potential stroke cases By Tom Greeson On April 11, 2022, the U.S. Food and Drug Administration (FDA) issued an open letter to health care providers reminding them about the...
4/4/2022 7:29:30 PM FDA updates thyroid monitoring guidance for babies and young children who receive injections of iodine-containing contrast media for medical imaging By Tom Greeson The U.S. Food & Drug Administration (FDA) has issued a new warning that adds to the agency's prescribing information when iodinated...
11/30/2021 5:39:39 PM FDA receives comments on making information about AI/ML-enabled medical devices more transparent By Tom Greeson In response to the U.S. Food and Drug Administration's (FDA's) virtual public workshop on transparency surrounding artificial...
11/17/2021 8:25:44 PM HHS Reverses Policy on Laboratory Developed Tests (LDTs) By Cori Goldberg There was a meaningful update from the U.S. Department of Health and Human Services (HHS) yesterday regarding FDA’s regulation of...
11/3/2021 1:54:35 PM FDA releases joint AI/machine learning guidelines with public health partners in Canada and the U.K. By Tom Greeson The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency...
9/30/2021 7:17:55 PM FDA clears new photon counting CT technology By Tom Greeson This morning, September 30, the U.S. Food and Drug Administration (FDA) cleared what the FDA describes as the "first new major...
9/27/2021 1:00:01 PM FDA posts new resource for locating approved AI/ML-enabled medical devices By Tom Greeson The U.S. Food and Drug Administration (FDA) has begun to gather and publish a list of medical devices that are enabled through software...
8/11/2021 7:20:40 PM FDA announces plans to regulate certain diagnostic imaging agents as devices, not drugs By Tom Greeson In a notice published in the Federal Register on August 9, 2021, the U.S. Food and Drug Administration (FDA) announced it will implement...
8/9/2021 11:07:42 PM FDA announces product recall for certain batches of ultrasound gel By Tom Greeson The Food and Drug Administration (FDA) has published a recall notice from Eco-Med Pharmaceuticals, Inc., a Canadian company, for certain...