News & Analysis as of

Supply Chain Public Health

Health Care Compliance Association (HCCA)

Privacy Briefs: August 2024

On July 19, Change Healthcare Ince. filed a breach report with HHS Office for Civil Rights (OCR) concerning its mammoth ransomware attack and breach. The organization’s breach report to OCR identifies just 500 individuals as...more

BakerHostetler

California’s Continuing Crusade Against PFAS-Containing Products

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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

Braumiller Law Group, PLLC

Hot Topics in International Trade - November 2023 - Any Comments on FDA’s New Proposed Rule on Prior Notice Regulations?

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires the Food and Drug Administration (FDA) to take additional measures for safeguarding the public against potential terrorist attacks on...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

Cadwalader, Wickersham & Taft LLP

Investor Coalitions Urge Consumer Goods Companies to Take Action to Reduce Plastics

In a statement released on May 3, 2023, the Dutch Association of Investors for Sustainable Development (VBDO) called for companies in the fast-moving consumer goods (FMCGs) and grocery retail sectors to reduce their...more

Dorsey & Whitney LLP

HHS and FDA Take Additional Measures to Aid Post-PHE Transition for Pharmacy Providers

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For the last three years, the federal government has taken considerable steps to aid providers in the fight against COVID-19. Although many of the waivers and flexibilities initiated in response to the pandemic have since...more

McDermott Will & Emery

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

Hogan Lovells

FDA releases systematic review of the scientific literature on food safety culture

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Last week, the U.S. Food and Drug Administration (FDA) released a systematic review of the scientific literature on food safety culture. The review was conducted as part of FDA’s New Era of Smarter Food Safety blueprint,...more

Clark Hill PLC

Window on Washington – Vol. 6, Issue 32

Clark Hill PLC on

Outlook for This Week in the Nation’s Capital - Congress. The House and Senate are both in recess until Labor Day. Once they return, they will have a packed to-do list ahead of the November elections, which may include...more

Harris Beach PLLC

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

Harris Beach PLLC on

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

White & Case LLP

Biden Administration Increases Domestic Content Requirements under Buy American Act, Enhances Price Preferences for Domestic...

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On March 7, 2022, the Federal Acquisition Regulatory Council (FAR Council) published a final rule that increases domestic content requirements for Federal government procurements governed by the Buy American Act (BAA). The...more

MoFo Life Sciences

FDA Releases Draft Guidance On Digital Health Technologies For Remote Data Acquisition In Clinical Investigations

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In response to COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) continues to work in support of clinical investigation sponsors and an evolving environment in which they run their clinical trials while...more

Environmental General Counsel PC

ESG Checklist -- A Prop 65 Compliance Program?

In California, the Proposition (“Prop”) 65 landscape continues to evolve – notices of violations (“NOVs”) issued for products that do not contain or emanate a Prop 65 chemical, novel constitutional theories raised by defense...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

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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

Foley & Lardner LLP

Executive Order on America’s Supply Chains

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On February 24, 2021, President Joe Biden signed an executive order with the policy goal of strengthening and diversifying supply chains in the United States (the “Order”). The Order was issued to combat various threats to...more

ArentFox Schiff

President Biden Orders 100-Day Review of America’s Supply Chains for Semiconductors, Batteries, Critical Minerals and APIs

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Changes are afoot for key industry sectors with complicated global supply chains. “As this pandemic has made clear, we can never again be in a position where we have to rely on a foreign country that doesn’t share our...more

Epstein Becker & Green

COVID-19 Vaccines: The Ethical and Legal Challenges to Immunization

The legal history of the current immunization delivery system for vaccines in the United States is complex and requires the coordination of many players, from manufacturers and distributors in the supply chain to health care...more

Obermayer Rebmann Maxwell & Hippel LLP

What’s in Store for Government Contractors: Biden’s Early Executive Orders, How they Might Affect You, and What to Watch Out For...

So far in 2021, President Biden has signed 30 executive orders (aka EOs).  While most of these orders are not aimed specifically at government contractors, several of them may nonetheless impact the operations of certain...more

Foley & Lardner LLP

Top 12 Biden Executive Orders Related to Healthcare and COVID-19

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During President Biden’s first few weeks in office, he signed 30 executive orders (EO), many of which are designed to improve and protect the safety, well-being, and future of the United States. This blog post provides a high...more

PilieroMazza PLLC

The First 100 Days: President Biden’s Plan to Secure a Sustainable Public Health Supply Chain, 3 Tips for Government Contractors

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In November, we published a post on potential Biden administration use of the Defense Production Act of 1950 (DPA) in response to the COVID-19 pandemic. In his first week in office, President Biden invoked the DPA and signed...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...

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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

Oberheiden P.C.

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

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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

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