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One important regulatory update to know is that in December 2024, the FDA confirmed that the tirzepatide shortage had been resolved [1]
Analytical guidance from ICH and FDA describes validation concepts for procedures used to evaluate identity, purity, assay, and related measurements [19] [20]
As a result, they may require higher doses or more frequent administration to achieve the desired results
This is different from platforms that use flat-rate pricing regardless of dose, and it means your total cost rises over time as your treatment progresses
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