Health Care Law News and Insights

House Clears Prescription Drug Price Transparency, Health Workforce Legislation

Published: Dec 01, 2020
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The House of Representatives has approved — without objection — a series of bills intended to promote prescription drug pricing transparency and invest in the health care workforce. With regard to drug pricing transparency, the House approved HR 2115, the Public Disclosure of Drug Discounts Act, as amended to include HR 3415,...

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Merger Of Adventist-St. Joseph Rejected By The California Attorney General

Published: Nov 29, 2020
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On October 31, 2019, the California Department of Justice ("DOJ") issued a denial letter rejecting a proposed merger between Adventist Health System/West and St. Joseph Health System. The parties had submitted notices to the DOJ requesting approval to form a joint operating company to manage the health systems' nine health facilities in...

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FDA Issues Final Guidance On PDUFA Waivers, Reductions, And Refunds

Published: Nov 27, 2020
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Introduction The Prescription Drug User Fee Act of 2017 (PDUFA VI) authorizes the U.S. Food and Drug Administration (FDA) to assess fees (PDUFA fees) when applicants submit new drug applications (NDAs). PDUFA fees are substantial. For example, the PDUFA fee for an NDA requiring clinical data will be $2,942,965 in 2020....

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