The U.S. Food and Drug Administration (FDA) has announced a groundbreaking initiative aimed at improving access…
Category: US
US / FDA updates on medical device regulation and quality.
FDA Introduces TEMPO Digital Health Pilot to Improve Chronic Disease Care Access
The U.S. Food and Drug Administration (FDA) unveiled the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital…
FDA Grants Conditional Approval for Cattle Treatment Addressing New World Screwworm and Fever Ticks
The U.S. Food and Drug Administration (FDA) has granted conditional approval for Exzolt Cattle-CA1 (fluralaner), a…
FDA Grants Approval to First CAR T-Cell Therapy for Marginal Zone Lymphoma in the U.S.
The U.S. Food and Drug Administration (FDA) has issued its approval for Breyanzi (lisocabtagene maraleucel) as…
FDA Grants Approval for Avance Nerve Scaffold to Treat Sensory Nerve Damage
The U.S. Food and Drug Administration (FDA) has approved Avance (acellular nerve allograft-arwx), marking a significant…
FDA Appoints Acting Director for Center for Drug Evaluation and Research
The U.S. Food and Drug Administration (FDA) announced the appointment of Tracy Beth Høeg, M.D., Ph.D.,…
FDA Issues Early Alert on Glucose Monitor Sensor Risks from Abbott Diabetes Care
The FDA has issued an Early Alert regarding a significant safety concern involving certain glucose monitor…
Critical Update: Olympus Modifies Use Instructions for Single Use Ligating Device PolyLoop
On December 3, 2025, the FDA announced a significant correction related to Olympus’s Single Use Ligating…
FDA Proposes New Measures to Minimize Non-Human Primate Testing for Monoclonal Antibody Development
The U.S. Food and Drug Administration (FDA) has released proposed guidance aimed at reducing or eliminating…
FDA’s Coordinated Crackdown: $1 Million Worth of 7-OH Opioids Seized in Missouri
The U.S. Food and Drug Administration (FDA), in collaboration with the U.S. Department of Justice (DOJ),…