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The FDA has given the company 15 business days to respond to the letters, in which they must include the steps they will take to rectify the violations

Ali, S

The primary endpoint was the presence of increased RCG, defined as, the presence of solids, thick liquids, or more than 1.5 mL/kg of clear liquids on gastric ultrasonography. Among the 124 subjects (median age, 56 years, 60% female), the prevalence of increased RGC was 56% (35 of 62) in subjects with GLP-1 RA use compared with 19% (12 of 62) in subjects not taking a GLP-1 RA drug

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