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262(k)(7)(A)-(B)
Do not claim the medication was boiling hot if it was just warm
This matters more at small volumes like 10 units where one marking off means a larger percentage error
Use of these drugs also was linked with a 4.22- and 3.67-times higher risk for bowel obstruction and gastroparesis, respectively
Everything below is compound-level evidence, presented so you can see what is and is not established
Patients experiencing significant weight loss may have different side effect profiles than those with minimal response
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