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Understanding the 2025 Medicare Part D Re-design: What You Need to Know

Innovaare Compliance

JANUARY 15, 2024

These changes mark a pivotal shift from its original structure in 2006. 6] A compound drug not approved by the FDA under a New Drug Application or Biological License Application does not meet the definition of an applicable drug and will not be eligible for Part D. Rebates from the selected drugs may change.

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Medicare Medicare Compliance FDA 52
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SQA Regulatory Surveillance Summary 4 | Monthly Update 2021

SQA

JUNE 10, 2021

The new regulation, RDC 478/2021 , repeals economic monitoring and reporting processes previously established under RDC 185/2006, and initially reduces the number of medical device types for which economic monitoring will be required. FDA plant inspection and pay $50 million in fines and forfeiture.

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FDA COVID-19 COVID-19 Vaccine Compliance 52
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