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Monthly Round-Up of What to Read on Pharma Law and Policy

Bill of Health

Frequency, Characteristics, And Outcomes Of Negative Advisory Committee Votes For FDA-Approved Drugs. Fixing The FDA’s Orange Book. Coverage of New Drugs in Medicare Part D. The global impact of COVID-19 on drug purchases: A cross-sectional time series analysis. Health Aff (Millwood). 2022 May;41(5):713-721.

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Monthly Round-Up of What to Read on Pharma Law and Policy

Bill of Health

Experts’ Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care. Medicaid Expenditures and Estimated Rebates on Line Extension Drugs, 2010-2018. 2022 Feb 19. Emergency Use Authorizations of COVID-19-Related Medical Products. 2022 Feb 24. Epub ahead of print.

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President Biden Signs End-of-Year Legislation Including Telehealth, Medicare & Medicaid, Mental Health, Pandemic Preparedness, and Other Health Care Provisions

C&M Health Law

Notably, the Act neither fulfilled the Biden Administration’s request for additional COVID-19 response funding nor included the Verifying Accurate Leading-edge In Vitro Clinical Test (IVCT) Development (VALID) Act, which proposed updating the current diagnostic testing regulatory framework.

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GOP House Opens With Abortion Agenda

Kaiser Health News

But Medicare is likely to be on the agenda, which will require the input of the chairs of both committees. On one hand, the FDA has relaxed some of the risk evaluation and mitigation strategies (REMS) from the prescribing rules surrounding abortion pills. Some advocates say these pills simply do not bring that level or risk.