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Federal health officials told insurers in a memo last month that they could substitute a less expensive Part B drug to treat a medical condition the FDA has not approved it for, if insurers can document that it is safe and effective

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For examples of how this approach to civil money penalties will work in practice, see section III.I.2.g

The correlative endpoint was a shift in antitumor immune profile in post-treatment tissue compared to pre-treatment tissue measured by qmIF

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