News & Analysis as of

Personal Protective Equipment Medical Supplies

Dickinson Wright

Wait, Wait…Don’t Sell Me! FDA and Other Pre-Market Considerations for Commercial Products

Dickinson Wright on

The Food and Drug Administration (FDA) is a consumer protection agency that ensures the safety and efficacy of certain products in the US, such as medical devices, drugs, and prescriptions, tobacco products, cosmetics, food,...more

Alston & Bird

Medical Products Supply Chain Week in Review – August 2021 #1

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Last week, the Centers for Disease Control and Prevention (CDC) revised its mask guidance for fully vaccinated individuals. Also, while the Administration and several health care institutions evaluate the possibility of...more

Vinson & Elkins LLP

FEMA Removes Some PPE Export Restrictions And Offers Exemption For Surplus Goods

Vinson & Elkins LLP on

On May 19, 2021, the Federal Emergency Management Agency (“FEMA”) announced that it is removing export restrictions on four categories of personal protective equipment (“PPE”) and other items used to address the effects of...more

Alston & Bird

COVID-19 Medical Products Supply Chain Week in Review - May 2021 #1

Alston & Bird on

In the past week, the U.S. government announced new vaccination milestones reached and encouraged more people to get vaccinated. Please see details for these and other supply chain developments below: On April 27, President...more

Epstein Becker & Green

Podcast: President Biden's Use of the Defense Production Act - Diagnosing Health Care

Epstein Becker & Green on

The Biden administration has invoked the Defense Production Act ("DPA") to speed up the production of vaccines and increase the domestic production of COVID-19 tests, personal protective equipment (or “PPE”), and other...more

Alston & Bird

COVID-19 Medical Products Supply Chain Week in Review – March 2021 #3

Alston & Bird on

In the past week, President Biden signed the American Rescue Plan, which provides $10 billion to expand domestic production of medical supplies. The President also announced that all adults in the U.S. will be eligible for...more

Troutman Pepper

DOJ’s Robust 2020 Pandemic Response Signals Increasing Focus on COVID-19-Related Fraud in 2021

Troutman Pepper on

Why It Matters - As evidenced in the recently published 2020 Year in Review Report (Report), the Department of Justice’s Fraud Section (Fraud Section) demonstrated its resilience despite the COVID-19 pandemic, as well as its...more

Jackson Lewis P.C.

Indiana Enacts COVID-19 Liability Shield For Hoosier Businesses

Jackson Lewis P.C. on

In an effort to stimulate safe reopening of the economy and protect companies acting in good faith, Indiana has enacted a COVID-19 immunity shield. Governor Eric Holcomb signed Indiana Senate Bill 1, “Immunity Related to...more

Spilman Thomas & Battle, PLLC

Unprecedented: COVID-19 Litigation Insights, Volume 2, Issue 2 - January 2021

Welcome to the second issue of the 2021 edition of Unprecedented. The first week of the Biden administration already has represented a shift to the federal government's approach to the COVID-19 pandemic. In addition to...more

BCLP

Government’s Power to Direct Priority of Deliveries

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At the outset of the Covid-19 outbreak in this country, President Trump invoked the Defense Production Act of 1950, as amended, to help combat the virus. In March and April, he issued executive orders under the powers...more

White & Case LLP

Primer: What Companies in the COVID-19 Vaccine Supply Chain Need to Know about the Defense Production Act

White & Case LLP on

The Korean-War era Defense Production Act ("DPA")1 has already loomed large in the federal response to the COVID-19 pandemic. Recent press reports suggest that it may be invoked even more broadly in the coming weeks and...more

Oberheiden P.C.

With Latest COVID-19 Surge, Federal Officials Will Be Prepared to Combat PPE Fraud

Oberheiden P.C. on

When the COVID-19 crisis struck in early 2020, the immediate need for mass quantities of personal protective equipment (PPE) resulted in major supply shortages that made headlines across the country. As suppliers scrambled to...more

Seyfarth Shaw LLP

More Than a Game Changer: Fourth Amendment to PREP Act Declaration Establishes Federal Jurisdiction, Bolsters Immunities, and...

Seyfarth Shaw LLP on

On December 3, 2020, the U.S. Department of Health and Human Services (HHS) issued another groundbreaking amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act). ...more

McDermott Will & Emery

Supporting Health Through Supply Chain Management

McDermott Will & Emery on

On this episode of Leaders Moving 2020 Forward, Chaun Powell, Group Vice President, Strategic Supplier Engagement with Premier, Inc. is interviewed by Jennifer Geetter, a partner in McDermott Will & Emery’s Health practice....more

Womble Bond Dickinson

Medical Rationing: Putting the Greatest Good to the Test?

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Medical rationing is not something Americans are accustomed to, but COVID-19 may soon change that. As local hospitals become overwhelmed with COVID-19 patients, they may reach the point where they have to make grim decisions...more

Wilson Sonsini Goodrich & Rosati

FDA Declines to Review Certain EUAs, Raising Reimbursement and Liability Issues

The Food and Drug Administration (FDA or the Agency) announced on October 7 that it will no longer review Emergency Use Authorizations (EUAs) for laboratory developed tests (LDTs). LDTs are a distinct category of in vitro...more

Jones Day

COVID-19 Key EU Developments, Policy & Regulatory Update No. 22

Jones Day on

This regular update (no. 22 | 22 September 2020) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal...more

Goulston & Storrs PC

Increased Charitable Giving in the Time of COVID: Philanthropy or Tax Driven?

Goulston & Storrs PC on

Even before the global COVID-19 pandemic hit, retailers across the country were already prioritizing charitable giving despite the existing downward trend in sales and revenue.  With the recent global COVID-19 pandemic and...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Umbrella EUA for Surgical Masks

The U.S. Food and Drug Administration (FDA) recently unmasked new guidance surrounding distribution of surgical masks. As a brief recap, on April 16, 2020, the FDA issued an Emergency Use Authorization (EUA) authorizing the...more

Akin Gump Strauss Hauer & Feld LLP

Executive Order on Essential Medicines: A Timeline and Overview of Key Provisions

On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more

Akin Gump Strauss Hauer & Feld LLP

FEMA Extends Temporary Final Rule Restricting Certain Exports of PPE

- On August 10, 2020, FEMA extended the duration of its restrictions on the export of certain shipments of PPE through December 31, 2020. - The August 10 notice narrowed the types of PPE covered by the restrictions to...more

Faegre Drinker Biddle & Reath LLP

FEMA Extends Halt of PPE Exports Through December 31, 2020

On Monday, August 10, 2020, the Federal Emergency Management Authority (FEMA) announced that it would continue to halt the export of certain personal protective equipment (PPE) until December 31, 2020. With this announcement,...more

Sheppard Mullin Richter & Hampton LLP

“Buy American” in the Twilight Zone: Executive Order Strengthening the U.S. Public Health Industrial Base

On August 6, 2020, President Trump signed the “Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States,” requiring, among other things, the U.S. government...more

Vinson & Elkins LLP

Update On FEMA’s Export Restrictions On Personal Protective Equipment

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On August 6, 2020, the Federal Emergency Management Agency (“FEMA”) issued a temporary final rule modifying the list of Personal Protective Equipment (“PPE”) subject to FEMA’s export restrictions and extending the...more

Hogan Lovells

FDA takes action to reduce surgical mask shortage

Hogan Lovells on

To address the increased usage and shortages of surgical masks as a result of combatting COVID-19, on August 5, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for disposable,...more

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