Information and interesting ideas

Topics posted here will be in the realm of bioanalysis and biomarkers as part of new therapeutic development, with the occasional post of scientific topics that I find interesting.

Thursday, May 18, 2023

CVS Steps out of clinical trial support

 After 2 years, CVS has decided that clinical trial support was no longer a part of its business mission.  That leaves Walgreen's and Walmart as pharmacy providers still in the game.  Nothing specific in the announcement provides what problems may have been encountered that led to the decision.  These problems may have already been solved by the remaining players, but if not, they would be valuable lessons for those still in the game.  With the continued need for patient support outside of physician offices and clinics, I am wondering how the industry will respond to keep decentralized trials available to the most patients, especially those in under served urban and rural areas.

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FDA and CMS issue statement on LDTs: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They Are Made

This joint statement notes the evolution of Laboratory Developed Tests (LDTs) from the initial rule and approach the FDA had for oversite, a...