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After consideration of public comments, we are finalizing the policy proposed at 427.303(b)(5) with a modification to align the policy described at 427.303(b)(5) with the policy as described in the CY 2025 PFS proposed rule (89 FR 61950)

In our experience working with researchers in this space, the most common dilution error is adding water to reach a 'convenient' syringe marking without calculating concentration first

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However, some orally-administered drugs are able to avoid first-pass metabolism , to some degree at least, as a result of lymphatic drug absorption