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Public Health Service Act Public Health Emergency

Foley Hoag LLP

The FDA Finalizes Transition Plan for Medical Device Authorizations and Policies Affected by Covid-19 PHE

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The Food and Drug Administration (FDA) has announced transition plans for Emergency Use Authorization (EUA)-authorized medical devices and devices marketed pursuant to COVID-19-related guidance documents. The Transition...more

Morgan Lewis

Preparing for the End of COVID-19 Emergency Periods: To-Dos for Plan Sponsors and Administrators

Morgan Lewis on

The COVID-19 pandemic brought multiple temporary changes for ERISA-governed group health and welfare plans. Certain coverage mandates apply for only the duration of the COVID-19 public health emergency (the Public Health...more

ArentFox Schiff

HHS COVID-19 Public Health Emergency Persists as California COVID-19 Policies Are Set To Expire

ArentFox Schiff on

The US Department of Health and Human Services’ (HHS) declaration that COVID-19 remains a public health emergency (PHE) will continue through July 15, 2022, and is expected to be renewed again through October 13, 2022....more

Hogan Lovells

FDA explains when medical device makers must notify of an interruption in manufacturing

Hogan Lovells on

On Monday, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act,” which aims to...more

McDermott Will & Emery

HHS Signals Commitment to “Predictability and Stability,” Extends Public Health Emergency Declaration “Likely” for Entirety of...

McDermott Will & Emery on

In a recent letter to state governors, Acting Secretary of Health and Human Services Norris Cochran signaled the US Department of Health and Human Services’ (HHS’s) commitment to “predictability and stability” in the ongoing...more

Foley Hoag LLP

Federal Public Health Emergency Extended to April 21, 2021

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On January 7, 2021, Secretary Azar of the U.S. Department of Health and Human Services extended the existing public health emergency for 90 days, until April 21, 2021. Without this extension, the declaration would have...more

Manatt, Phelps & Phillips, LLP

HHS Renews the COVID-19 Public Health Emergency Through January 20, 2021

On Friday, October 2, the U.S. Department of Health & Human Services (HHS) announced that the Public Health Emergency (PHE) declaration for COVID-19 will be renewed for another 90 days, beginning on October 23 (the date the...more

Foley & Lardner LLP

Federal Residential Evictions Moratorium Update

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On September 4, 2020, to prevent the further spread of COVID-19, the Centers for Disease Control and Prevention (“CDC”) issued an Order under Section 361 of the Public Health Service Act to temporarily halt residential...more

Manatt, Phelps & Phillips, LLP

HHS Renews COVID-19 Public Health Emergency, Extending Flexibilities and Funding for Another 90 Days

On Thursday, July 23, the U.S. Department of Health & Human Services (HHS) announced that the Public Health Emergency (PHE) declaration for COVID-19 will be renewed for another 90 days through October 22. This update...more

Arnall Golden Gregory LLP

Patients Over Paperwork: CMS Issues Blanket Waivers on Stark Law Sanctions in Response to COVID-19

Extraordinary times call for extraordinary measures – this is the approach the Centers for Medicare and Medicaid Services (“CMS”) has taken with respect to the federal Physician Self-Referral Law (the “Stark Law”) by issuing...more

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