WASHINGTON, May 8, 2024 – In response to President Biden’s Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy,” the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) have developed a plan to update, streamline, and clarify their regulations and oversight mechanisms for products of biotechnology.Continue reading
Author Archive: AZBio
ASU researchers develop AI-based tool paving the way for personalized cancer treatments
New freely available tool uncovers new insights into how our body distinguishes between our own cells and potential invaders with unprecedented speedContinue reading
AHCCCS Unveils New Agency Structure, Grows Leadership Team
Five new divisions created to address agency goalsContinue reading
Lasering USA Announces Strategic Partnership with Aesthetic Biomedical® Inc.
Two Technologies Combine to deliver unrivaled Facial Skin RejuvenationContinue reading
FDA Final Rule on Medical Devices; Laboratory Developed Tests Published May 6, 2024
Medical Devices; Laboratory Developed Tests, a rule by the Food and Drug Administration was published on the Federal Register on 05/06/2024. The rule is effective July 5, 2024.Continue reading
SynCardia Total Artificial Heart Saves Another Life at Cincinnati Children’s
Implant Marks Over 2080 Total SynCardia Total Artificial Heart CasesContinue reading
Sensitive and Specific: Special Report on FDA final rule on LDTs
This week, the FDA released its long-awaited final rule on the regulation of laboratory-developed tests (LDTs).
Along with the rule, the agency published drafts of two guidance documents covering its enforcement policy for LDTs that are created “for immediate response to an emergent situation, such as an outbreak of an infectious disease.” One document covers enforcement when a public-health emergency hasn’t yet been declared; the other covers enforcement once the nation is in an official public-health emergency. Continue reading
CommonSpirit Health Appoints Anthony Houston President of its Arizona Market
PHOENIX (May 1, 2024) – CommonSpirit Health, the parent organization of Dignity Health, has named Anthony Houston, EdD, FACHE, president of its Arizona market. The organization’s Arizona market comprises eight acute care hospitals, a medical group, graduate medical education programs, imaging centers, specialty hospitals, urgent cares, freestanding emergency departments, insurance providers, an accountable care organization and other clinical partnerships. Houston will begin his duties this summer. Continue reading
New Video Explains the Impact of The Bayh Dole Act on American Innovation
Bayh-Dole Coalition Launches Campaign Against Proposed March-in Framework.
GT Medical Technologies, Inc. and Theragenics Corporation Forge Distribution Partnership for Cesium-131
Extending Beyond Brain Tumors, Empowering Patients with Treatment Options in Prostate Cancer and Other MalignanciesContinue reading