After bringing up the topic many times over the past two decades, the FDA has finally done it: They’ve issued a proposed rule that would eliminate the agency’s enforcement discretion over laboratory-developed tests (LDTs), integrating LDTs into the FDA’s oversight over a period of four years. This issue has been top of mind for the FDA and most everyone in the diagnostics ecosystem for many years. The change has the potential to be a very big deal. Whether for good or bad depends on your viewpoint.Continue reading
Category Archives: AZBio News
HonorHealth Research Institute clinical trial helps secure FDA approval of revolutionary new pacemaker
World’s first dual chamber leadless pacemaker successfully implanted in 22 HonorHealth patients, stimulating two heart chambers without using wiresContinue reading
HonorHealth Research Institute potentially part of 8,000-patient global clinical trial to test drug that might prevent severe bleeding
SCOTTSDALE, Ariz. — Oct. 4, 2023 — HonorHealth Research Institute is consulting the people of Scottsdale and Phoenix about whether to lead a local trauma research study to investigate a blood clotting agent as a treatment for trauma patients who are bleeding to death.Continue reading
Novartis executes Sandoz Spin-off, completing strategic transformation into a leading, focused innovative medicines company
The Spin-off of Sandoz enables Novartis to complete its transformation to become a leading, focused medicines company. With capital allocation and management attention fully focused on innovative medicines, Novartis is well-positioned for sustained top- and bottom-line growth.Continue reading
Ceria Therapeutics, Inc. Awarded a $3,800,000 DoD Contract to Advance Development of a Novel Treatment for Acute Lung Injuries.
The award will go towards the development of CTX-002 in preparation for clinical studies.
Student-faculty team of inventors spin out tools to remove stuck orthpedic screws
Startup Ancerix to commercialize much needed tool kit for surgeons
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Castle Biosciences Shares New Data Demonstrating Ability of TissueCypher® Test Results to Inform Clinical Decision-Making in Patients with Non-Dysplastic Barrett’s Esophagus
Data shared via a poster presentation at the recent American Foregut Society (AFS) Annual MeetingContinue reading
ACLA Opposes Unilateral FDA Action to Regulate Laboratory Developed Tests Under Medical Device Authority
Washington, D.C. – The American Clinical Laboratory Association (ACLA) today issued the following statement after the U.S. Food and Drug Administration (FDA) released a proposed rule that would seek to regulate Laboratory Developed Tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act. ACLA does not believe that FDA’s actions are in the best interest of patients or our nation’s health care system. Because the proposed rule exceeds FDA’s existing authority, ACLA plans to submit comments urging FDA to withdraw the proposed rule and resume work with Congress, the laboratory community, patient groups, and other stakeholders toward a legislative solution that provides a framework that is appropriate for the unique attributes of LDTs.Continue reading
FDA Proposes Rule Aimed at Helping to Ensure Safety and Effectiveness of Laboratory Developed Tests
For Immediate Release:
September 29, 2023
Today, the U.S. Food and Drug Administration announced a proposed rule regarding laboratory developed tests, or LDTs, which play an important role in healthcare. The rule is aimed at helping to ensure the safety and effectiveness of these tests, which are used in a growing number of health care decisions and for which concerns have been raised for many years.Continue reading