Looming Government Shutdown Opens Door for Congress to Possibly Pass Clinical Laboratory Bills

Two former FDA commissioners who support changing oversight of laboratory-developed tests (LDTs) say FDA’s regulatory playbook is ‘outdated’ Congress’ attempts to avoid a government shutdown due to a lack of funding presents a final chance this year for two different clinical laboratory bills to be pushed through. The Verifying Accurate Leading-edge IVCT Development (VALID) Act and Saving Access to Laboratory Services Act (SALSA) could be added to a year-end spending package that will fund...

Monkeypox Outbreak Subsides in US, Europe, But Public Health Concerns Remain

Experts cite high vaccination rates and behavioral changes among at-risk groups, but warn about complacency; clinical laboratories should remain vigilant In July, Scott Gottlieb, MD, Commissioner of the US Food and Drug Administration (FDA) from May 2017 to April 2019, wrote an op-ed in The New York Times titled, “Monkeypox Is About to Become the Next Public Health Failure.” In it, he wrote, “Our country’s response to monkeypox has been plagued by the same shortcomings we had with COVID-19.”...

FDA Issues its First Emergency Use Authorization for an Antigen-based Diagnostic as Top IVD Manufacturers Race to Supply Medical Laboratories with COVID-19 Tests

Though experts say an antigen test is not as accurate as PCR tests, its low cost, ease of use, and widespread availability make it a boon for clinical labs performing COVID-19 testing While COVID-19 exploded around the world, the US Food and Drug Administration (FDA) unleashed the nation’s in vitro diagnostics developers by issuing dozens of Emergency Use Authorizations for new coronavirus laboratory-developed tests (LDTs). Most of these EUAs are for Reverse Transcription-Polymerase Chain...

Harvard ‘Roadmap’ to Recovery Calls for ‘Massive’ Increase in Clinical Laboratory COVID-19 Testing in Four-Phase Blueprint for Reopening Economy

Report’s authors claim the US needs to be testing 20-million people per day in order to achieve ‘full pandemic resilience’ by August Medical laboratory scientists and clinical laboratory leaders know that the US’ inability to provide widespread diagnostic testing to detect SARS-CoV-2—the novel coronavirus that causes the COVID-19 illness—in the early stages of the outbreak was a major public health failure. Now a Harvard University report argues the US will need to deliver five million tests...

FDA, IBM, Merck, Walmart and KPMG Collaborate on Blockchain Pilot Project to Track Pharmaceuticals

First used to track cryptocurrencies such as Bitcoin, blockchain is finding its way into tracking and quality control systems in healthcare, including clinical laboratories and big pharma Four companies were selected by the US Food and Drug Administration (FDA) to participate in a pilot program that will utilize blockchain technology to create a real-time monitoring network for pharmaceutical products. The companies selected by the FDA include: IBM (NYSE:IBM), Merck (NYSE:MRK), Walmart...
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