News & Analysis as of

Public Health Supply Chain Manufacturers

Carlton Fields

Executive Order Seeks to Build Resilience in Pharmaceutical Supply Chains

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On August 13, 2025, President Trump signed an executive order aimed at strengthening America’s pharmaceutical supply chains. Officially titled “Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic...more

Foley Hoag LLP

FDA Launches PreCheck Program to Accelerate Onshoring of Drug Manufacturing Facilities

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Key Takeaways: - The FDA PreCheck program, launched in response to Executive Order 14293, is designed to streamline and expedite the construction and approval of domestic drug manufacturing facilities, aiming to reduce...more

BakerHostetler

[Podcast] FDA-Regulated Products Supply Chain Disruptions: Industry Perspective

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Supply chain disruptions have become a significant challenge for the U.S. FDA-regulated products industry, affecting the availability of pharmaceuticals, medical devices, and food. These disruptions are caused by various...more

BakerHostetler

California’s Continuing Crusade Against PFAS-Containing Products

BakerHostetler on

A series of recent California laws have placed significant restrictions on the sale of certain products in the state that contain intentionally added perfluoroalkyl and polyfluoroalkyl substances (PFAS). California hopes, by...more

Thomas Fox - Compliance Evangelist

The Impact of PFAS ‘Forever Chemicals’ in Product Compliance

I recently had the opportunity to visit with Cally Edgren, a Senior Director of the Regulatory Expert team at Assent, who has nearly three decades of experience in manufacturing and has dedicated her career to helping...more

Knobbe Martens

FDA Updates Medical Device Shortages List

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The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory Reagents and Testing Supplies, Transport Media Device, Saline Vascular Access Flush, and Certain Ventilation-Related Products....more

McDermott Will & Schulte

Special Report - 2022 FDA Year in Review

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

Harris Beach Murtha PLLC

Division Y-Cyber Incident Report for Critical Infrastructure Act of 2022 Becomes Law, with Regulations Expected by 2025

Division Y – Cyber Incident Reporting for Critical Infrastructure Act of 2022 was signed into law by President Biden on March 15. Highlights of the Act include: ...more

Foley & Lardner LLP

Senate HELP Committee’s PREVENT Pandemics Act Draft Released: What to Know

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Following nearly a year of committee hearings, research, policy briefs, and discussion with agency experts, the Senate Health, Education, Labor, and Pensions (HELP) Committee Chairwoman Patty Murray (D-WA) and Ranking Member...more

Arnall Golden Gregory LLP

Tell Me, I’ve Got to Know: FDA Issues Draft Guidance on 506J Notifications for Medical Devices

Bob Dylan sang, “Tell Me, I’ve Got to Know.” In January 2022, the Food and Drug Administration said the same to the medical device industry when it issued a draft guidance, “Notifying the FDA of a Permanent Discontinuance or...more

Hogan Lovells

The TGA and the Iron Mask

Hogan Lovells on

In 2020, heightened demand for health care resulted in an influx of therapeutic goods being included on the Australian Register of Therapeutic Goods (ARTG). A large portion of these goods are manufactured in China however,...more

Oberheiden P.C.

DEA Compliance for 2021 - How the DEA’s 2021 Proposed Aggregate Production Quotas Affect Pharmaceutical Companies and Society

Oberheiden P.C. on

The DEA struggles to balance the pressing need to provide pain relief for those suffering from the novel coronavirus with the ongoing effort to reduce the opioid epidemic in the United States. I. Overview on the DEA and 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

Goodwin

U.S. Cares Act Supply Shortage Provisions: What Drug And Device Manufacturers Need To Know

Goodwin on

On March 27, 2020, President Trump signed into law the Coronavirus Aid, Relief, and Economic Security (CARES) Act in response to the U.S. COVID-19 pandemic. Throughout the COVID-19 outbreak, there has been public discussion...more

Foley & Lardner LLP

Implications for the Fashion, Apparel & Beauty Industries Due to the Coronavirus

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Like other industries, the fashion, apparel & beauty businesses have been, and continue to be hit hard by the COVID-19 pandemic. The $400 billion dollar American fashion industry employs over four million people, excluding...more

Kelley Drye & Warren LLP

EPA Expands List of Approved Coronavirus Disinfectants

The U.S. Environmental Protection Agency (EPA) continues to expand the number of surface disinfectants approved for use against coronavirus, announcing the addition of 70 new products to the agency’s “List N: Disinfectants...more

Goulston & Storrs PC

Coronavirus: Impact on the Retail Industry

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Coronavirus Disease 2019 or “COVID-19” continues to dominate national and international discussion. News outlets in Boston, New York, London, Mumbai, Rio de Janeiro, Tokyo, and every other city and town in the world continue...more

Hogan Lovells

FDA postpones foreign inspections amid growing concerns over coronavirus (COVID-19)

Hogan Lovells on

On 10 March 2020, FDA announced that it is postponing most foreign inspections through April 2020.  This action comes as the latest in a series of agency responses to the coronavirus (COVID-19) outbreaks in foreign...more

Polsinelli

COVID 19 and Supply Chain Contracts

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Covid-19 has caused serious disruption to manufacturers’ ability to produce products and fill orders on a timely basis, which in turn has impeded the performance of countless supply chains....more

ArentFox Schiff

Coronavirus Crisis: What US Retail Companies Need to do to Protect Against Business Implications

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As the coronavirus continues to wreak havoc globally, long-term business implications are imminent for US companies. The fashion and retail industries are specifically affected due to the volume of goods produced in China,...more

Foley & Lardner LLP

Managing the Commercial Impact of the Coronavirus: Implications for the Energy Industry

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The coronavirus (provisionally named SARS-CoV-2, with its disease being named COVID-19) has now been documented in more than 100 countries and territories. Over 110,000 cases have now been documented across the globe,...more

Akin Gump Strauss Hauer & Feld LLP

International Trade Impacts of The Coronavirus: Update On Government And Industry Actions And Key Considerations For Trade...

The new coronavirus, SARS-CoV-2, and the disease it causes, COVID-19, have created diverse, complex, and immediate challenges for world governments, multinational businesses, and other international institutions and projects....more

Foley & Lardner LLP

Coronavirus: Considerations for an Emergency Supply-Chain Response Plan

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We are in "unchartered territory" with the coronavirus, or COVID-19, according to the the World Health Organization's Director-General Tedros Adhanom Ghebreyesus. The virus has been documented in more than 70 countries and...more

Goulston & Storrs PC

An Unintended Interruption to the Global Supply Chain

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The current outbreak of COVID-19 (the coronoavirus) will be a test of the global supply chain’s strength in the face of unintended interruptions, and can be a lesson on building-in supply-chain contingency plans.  As a result...more

Robinson+Cole Construction Law Zone

Who Will Bear the Risk and Cost for Coronavirus Construction Delays? A Contractual Analysis.

As the Coronavirus spreads across the globe, its impact continues to disrupt many industries, including construction.  Over the last twenty years, the construction industry in the United States has substantially increased its...more

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