House lawmakers today unveiled a new draft of the BIOSECURE Act. Shortly after, BIO President and CEO, John F. Crowley, made the following statement:

“The BIOSECURE bill released in the House today reinforces the national security imperative of the biotechnology industry as a critical strategic asset of the United States of America. It highlights a key vulnerability in our global supply chain and importantly provides a reasonable timeframe for companies to decouple their reliance on China-based biomanufacturing. It ensures during this transition that important biomedical research will not be slowed and that patients will have unimpeded access to life saving medicines.Continue reading→

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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→

New freely available tool uncovers new insights into how our body distinguishes between our own cells and potential invaders with unprecedented speedContinue reading→

Five new divisions created to address agency goalsContinue reading→

Two Technologies Combine to deliver unrivaled Facial Skin RejuvenationContinue reading→

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→

Implant Marks Over 2080 Total SynCardia Total Artificial Heart CasesContinue reading→

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→

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→