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CMS intends to use the shortage lists maintained by the FDA Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) to determine whether a Part D rebatable drug is currently in shortage [592] during an applicable period

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Regulatory frameworks will continue to play a significant role in shaping the industrys direction

"You know, there's not a formal policy in place in terms of a certain amount of time," Norton said

Many policymakers have questioned the justifications for these integrity fees and only three states (Illinois, Michigan, and Tennessee) have adopted them

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