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We stated in the CY 2025 PFS proposed rule (89 FR 61974) that 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 [700] during an applicable period

The research uses a corpus of documents, including field reports and grant application documents, from the ten SURE-projects, and hence it provides a window into the often-ignored part of applied research like activity reports and other forms of knowledge transfers

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