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Importantly, where one warning letter recipient claimed that use of the self-collection kit was permissible because the related test was an LDT, FDA responded that the kit itself is a regulated medical device and not part of an LDT

How Payer Friction and Patient Drop-Off Undermine Obesity GLP-1 Uptake The GLP-1 market is experiencing unprecedented demand, yet despite its clinical promise for obesity, diabetes, and other conditions, patient behavior and friction throughout the treatment journey continue to erode its commercial potential

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