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Life Sciences › Patient Protection and Affordable Care Act (PPACA) › Food and Drug Administration (FDA)

McDermott+

It’s Raining Regs: CMS Releases Major Laboratory-Developed Test Reg in Midst of Massive Reg Storm

McDermott+ on

Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Approves Another Interchangeable Biosimilar Drug

McDonnell Boehnen Hulbert & Berghoff LLP on

On October 15th, the Food and Drug Administration approved its second interchangeable biosimilar drug.  That drug is Cyltezo (adalimumab-adbm), produced by Boehringer Ingelheim, which obtained biosimilar approval on August...more

Hogan Lovells

[Webinar] Looking ahead to 2021: Impacts of the election for the life sciences and health care industry - November 19th, 12:30 pm...

Hogan Lovells on

Life Sciences and Health Care Horizons virtual event series - The fast pace of innovation in the life sciences and health care industry has reached an all-time high in 2020 as the industry grapples with the new reality of...more

Hogan Lovells

Trump administration reversal would take away FDA’s authority to approve biosimilars

Hogan Lovells on

On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions of the Patient Protection and Affordable...more

Mintz - Health Care Viewpoints

Health Care Provisions in 2020 Spending Package

Mintz - Health Care Viewpoints on

On December 20, 2019, the President signed into law a bill to fund the federal government through September 30, 2020. The bill included several important health care provisions but left some longstanding policy challenges...more

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden's 2019 Insights: Trump Policy Actions Could Reshape Health Care and Life Sciences Landscape

Skadden, Arps, Slate, Meagher & Flom LLP on

In 2018, President Donald Trump and numerous executive branch agencies announced proposals that, if implemented, will reshape the landscape for virtually every sector of the health care industry. Many of these proposals are...more

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