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The data for ceftizoxime, a drug predominantly renally excreted unchanged, support this expectation, with the half-life increasing from 13 min in a mouse to 65 min in a dog, and close to 80 min in humans (Fig 22-7)

Second, as stated above, we wish to clarify that the definition of DMHT device as proposed would include devices cleared under section 510(k) of the FD&C Act or granted De Novo authorization by FDA

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