>> At-home tests could be getting a closer look
>> New eczema drug gets scratched
>> Female scientist recognized in a big way
The Med & Mic™ 10.2.23
MED NEWS blog post from Dr. Maria ON Speaking, LLC
FDA Increases Oversight of Medical Tests
The FDA is proposing more scrutiny of “laboratory-developed tests,” which are developed by individual labs. Originally, the laboratory-developed tests were based in hospitals and academic medical centers. They have now expanded to the direct-to-consumer marketplace with genetic tests and other specialty assessments. Millions of people use these products without knowing they don’t meet the same standards as other types of medical analysis. Under its purview, the FDA approves the mechanisms for blood, saliva, and tissue examination. A new FDA rule would require manufacturers to register their tests with the FDA, and the agency would evaluate the risks to consumers. The FDA has collected anecdotal reports of harm, which has prompted the increased regulation. (Source: CNN, B. Goodman, 9.29.23)
Eczema Drug Thwarted
The FDA has declined to approve a new drug for eczema due to inspection findings at the manufacturing plant. The monoclonal antibody from Eli Lilly has been studied in more than 1,000 patients with moderate-to-severe eczema who were not getting symptom relief with other treatments. The company says the rejection was not based on the clinical trial data or safety concerns. (Source: Reuters, 10.2.23)
Nobel Prize for Vaccine Researchers
Katalin Kariko and Drew Weissman have won this year’s Nobel Prize in Medicine. Their work on mRNA vaccines made COVID immunization possible. They published their first work in 2005 when they were colleagues at the University of Pennsylvania. (Source: Scientific American, LJ Young, 10.2.23)
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