New Legislation Would Jeopardize Patient Access to Medical Tests Across the Board by Restricting Policy that Removed Barriers to Coronavirus Testing

On March 5, U.S. House and Senate lawmakers introduced the VALID Act, which would give the Food and Drug Administration (FDA) new, expansive powers to regulate laboratory developed tests—tests that are already regulated by the Centers for Medicare and Medicaid Services (CMS) and are subject to stringent personnel, quality control, and proficiency testing requirements. This bill promotes duplicative, costly federal regulations for clinical laboratories that will result in decreased patient access to essential medical tests. AACC urges Congress not to act on this bill until its impact on healthcare can be thoroughly evaluated.

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AACC Statement on New FDA Guidance That Allows Certified Labs to Perform Coronavirus Testing

AACC thanks the FDA for being responsive to the concerns of the clinical laboratory community and amending the coronavirus guidance to allow CMS-certified labs to develop and implement new tests for coronavirus prior to FDA approval.

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Researchers Show How Ebola Virus Hijacks Host Lipids

Robert Stahelin studies some of the world’s deadliest viruses. Filoviruses, including Ebola virus and Marburg virus, cause viral hemorrhagic fever with high fatality rates. Stahelin, professor at Purdue University, examines how these viruses take advantage of human host cells.

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ISPOR-FDA Summit 2020 Will Focus on the Use of Patient-Preference Information in Medical Devices

ISPOR—the professional society for health economics and outcomes research, announced that it will be holding a joint ISPOR-FDA Summit, “Using Patient-Preference Information in Medical Device Regulatory Decisions: Benefit-Risk and Beyond,” on March 31, 2020 in Silver Spring, MD, USA.

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FDA awards $1.7 million to IU and other universities for quality management research

The U.S. Food and Drug Administration has awarded $1.7 million to five universities, including Indiana University, for a wide-ranging research project designed to help the agency better understand how to employ its quality management resources when inspecting drug companies’ manufacturing operations, thus benefiting consumers.

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