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Executive Orders Medical Devices

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Ankura

FDA Authorized to Establish New Cybersecurity Standards for Medical Devices: What it Means for Industry

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On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...more

Alston & Bird

FDA Extends Pause on Non-mission-critical Domestic Surveillance inspections to February 4 – Medical Products Supply Chain Week in...

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In this week’s issue, OSHA withdrew its emergency temporary standard (ETS), which required a mandatory vaccination policy for large private employers with an exception for employers that adopt a policy requiring mandatory...more

Sheppard Mullin Richter & Hampton LLP

“Buy American” Update: Essential Medicines May Continue to Come From Abroad (For Now)

The Biden Administration has taken (at least temporarily) the teeth out of a Trump-era Executive Order that directed the government to “Buy American” for essential drugs and medical devices. President Trump’s August 2020...more

Sheppard Mullin Richter & Hampton LLP

“Buy American” Update: FDA Issues List Of Essential Medicines Required By Executive Order

On October 30, 2020 the FDA published a list of essential medicines, medical countermeasures, and critical inputs as required by President Trump’s August 2020 Executive Order on Ensuring Essential Medicines, Medical...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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Tuesday, 20 October 2020 - President Trump’s executive order on essential medicines aims to encourage pharmaceutical companies to bring their manufacturing back to the U.S. But it may also have unintended consequences for...more

Saul Ewing LLP

CMS Proposes Medicare Coverage of Certain New Medical Devices, Clarification of “Reasonable and Necessary” Definition

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On September 1, 2020, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register a proposed rule that, if finalized, would establish a Medicare coverage pathway to provide Medicare beneficiaries with...more

Wilson Sonsini Goodrich & Rosati

CMS Proposes Basic Changes for Medicare Coverage, Including a New Reimbursement Pathway for FDA-designated Breakthrough Medical...

On August 31, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that, if finalized, would entail changes in Medicare coverage. (“Medicare Coverage of Innovative Technology (MCIT) and Definition...more

Foley & Lardner LLP

What You Need to Know about President Trump’s Executive Order to Strengthen the Domestic Supply Chain for Essential Drugs and...

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On August 6, 2020, President Trump signed an Executive Order (“Order”) to ensure essential medicines, medical countermeasures, and critical inputs are made in the United States. The President recognized that reliable...more

Manatt, Phelps & Phillips, LLP

President Trump Signs Executive Order to Encourage U.S. Manufacturing of Essential Medications

On August 6, President Trump signed an Executive Order, Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States, designed to reduce U.S. dependency on foreign sources of...more

Hogan Lovells

Buy American EO applies domestic preferences for "essential medicines" and "medical countermeasures"

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On August 6, 2020, U.S. President Donald Trump issued his much-anticipated "Buy American" Executive Order (EO), intended to increase and support domestic manufacture and Federal government procurement of "essential...more

Spilman Thomas & Battle, PLLC

The “Preventing Essential Medical Device Shortages Act of 2020”: COVID-19 Side Effect that Could Permanently Harm Medical Device...

The ongoing COVID-19 pandemic crisis—infecting more than 2.7 million people worldwide, with almost 870,000 cases in the United States alone as of the writing of this article—has thrown nearly every industry into chaos as the...more

Foley & Lardner LLP

Mexican Government's Actions to Streamline the Purchase, Imports and Authorization of Health Supplies, Drugs, and Medical Devices...

Foley & Lardner LLP on

Due to the current COVID-19 outbreak in Mexico, and the corresponding force majeure health emergency that has been declared in the country, the Mexican Government´s health services and most of the health care provided by the...more

Dentons

Iowa Residential Landlords Need to Understand Their Limited Options for Non-Paying Tenants in Light of State and Federal Covid-19...

Dentons on

The various state and federal COVID-19 orders and legislation enacted within the last week have resulted in a more complicated analysis of the implications for Iowa residential landlords, which is detailed herein. Iowa...more

Troutman Pepper

N.J. Order Authorizes Commandeering Of Medical Resources And Other Property

Troutman Pepper on

On April 2, New Jersey Gov. Phil Murphy issued Executive Order 113, authorizing the New Jersey State Director of Emergency Management to use the governor’s full authority under the Disaster Control Act to commandeer personal...more

Fox Rothschild LLP

Does The Defense Production Act Shield Manufacturers From Patent Infringement Risk?

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An Executive Order from President Trump that referred to the Defense Production Act has some manufacturers asking: are we now shielded from patent infringement liability if we produce otherwise-patented protective equipment...more

Troutman Pepper

N.J. Order Suspends Elective Medical Procedures, Seeks Medical Supplies From Businesses

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On March 23, New Jersey Gov. Phil Murphy issued Executive Order 109 — the state’s latest directive relating to COVID-19. ...more

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - August 2019

ANTICORRUPTION DEVELOPMENTS - Telecommunications Company Fined $12 Million for FCPA Violations - On August 29, 2019, The Securities and Exchange Commission (SEC) instituted ceaseand-desist proceedings against...more

Wilson Sonsini Goodrich & Rosati

President Trump Issues Executive Order on Advancing Kidney Health

On July 10, 2019, President Trump issued an Executive Order on Advancing American Kidney Health (the EO). Executive orders are issued under the authority of the Constitution, Article II, Sections 1 and 3, requiring that the...more

Hogan Lovells

[Webinar] Health Care and the Internet of Things: New Regulatory Developments - July 25th, 2:00pm EDT

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Please join the Hogan Lovells Communications and FDA practices on Thursday, July 25th for our webinar, Health Care and the Internet of Things: New Regulatory Developments. We will explore new policy initiatives and...more

BakerHostetler

FDA and Pharmacy Weekly Digest - July 2019 #1

BakerHostetler on

Food/Dietary Supplements - FDA Issues Report on Certain Dog Foods – The Food and Drug Administration (FDA) continues to investigate cases of dilated cardiomyopathy (DCM) in dogs consuming certain dog foods. ...more

Skadden, Arps, Slate, Meagher & Flom LLP

As Congress Struggles With ACA Repeal, Trump Administration Moves Forward With Regulatory Reform

The Trump administration and Republican-led Congress spent substantial time and political capital in 2017 on efforts to repeal and replace the Affordable Care Act (ACA) and enact sweeping Medicaid reform. By the end of the...more

McDermott Will & Emery

FDA 2017 Year in Review

McDermott Will & Emery on

The US Food and Drug Administration’s (FDA’s) 2017 regulatory agenda was marked by inactivity in the months following the presidential inauguration. Since FDA Commissioner Scott Gottlieb’s Senate confirmation in May 2017, the...more

Akin Gump Strauss Hauer & Feld LLP

President Trump and OFAC Announce Targeted Economic Sanctions on Venezuela

On August 25, 2017, President Trump issued an Executive Order (EO) imposing economic sanctions related to Venezuela. The new measures prohibit U.S. persons from engaging in certain debt-, equity-, and securities-related...more

Akin Gump Strauss Hauer & Feld LLP

What’s New in Washington: 10 Things You Need to Know

As the Trump presidency completes its first 10 weeks, the administration is celebrating big wins on the regulatory reform front while nursing some wounds from a major defeat on efforts to repeal and replace the Affordable...more

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