EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology

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

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