News & Analysis as of

Public Health Risk Management Manufacturers

BakerHostetler

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

BakerHostetler on

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

Morris James LLP

Analyzing the Impact of Recent Studies Linking Depo-Provera to Increased Meningioma Risk

Morris James LLP on

Recent scientific research has uncovered a significant association between the long-term use of Depo-Provera, a widely used injectable contraceptive, and the development of meningiomas, tumors affecting the membranes...more

Butler Snow LLP

Turnabout is Fair Play – “Junk Science” Litigation Aftermath: Requisite Retractions and Dubious Do-Overs

Butler Snow LLP on

Do plaintiffs’ experts get to put junk science before juries more often than their opinions are excluded? The answer is a resounding “probably.” Even in light of the December 2023 amendment to Federal Rule of Evidence and its...more

Blake, Cassels & Graydon LLP

Canada Publishes Final State of Per- and Polyfluoroalkyl Substances (PFAS) Report

Introduction - The Government of Canada has announced its intention to designate PFAS, a family of thousands of human-made chemicals known for their oil- and water-resistant properties, as “toxic” under the Canadian...more

Bergeson & Campbell, P.C.

EPA Will Extend Deadline for Reporting Health and Safety Data for 16 Chemicals

The U.S. Environmental Protection Agency (EPA) announced on March 6, 2025, that it plans to issue a rule “soon” to extend the reporting deadline for a rule under Section 8(d) of the Toxic Substances Control Act (TSCA)...more

McGlinchey Stafford

Defending Manufacturers Against PFAS Claims: Legal Strategies and Challenges

McGlinchey Stafford on

As litigation involving per- and polyfluoroalkyl substances (PFAS) continues to rise, manufacturers of PFAS-containing products face significant legal and financial risks. Plaintiffs, including individuals, communities,...more

BakerHostetler

Navigating FDA’s Guidance on Validation and Verification of Analytical Testing Methods for Tobacco Products

BakerHostetler on

The Food and Drug Administration (FDA) recently issued a final guidance document, Validation and Verification of Analytical Testing Methods Used for Tobacco Products. This nonbinding guidance provides tobacco product...more

Hogan Lovells

FDA Draft Guidance Addresses Management of Environmental Pathogen Hazards for Low-Moisture Ready-to-Eat Foods

Hogan Lovells on

On January 6, the U.S. Food and Drug Administration (FDA) issued long-awaited draft guidance regarding Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a...more

Vorys, Sater, Seymour and Pease LLP

EPA Releases Final Rules for TCE and PCE Under the Toxic Substances Control Act

The U.S. EPA recently announced that it released new risk management rules under the Toxic Substances Control Act (TSCA) for TCE and PCE.1 Manufacturers and other industrial clients need to be cognizant of these new rules...more

Troutman Pepper Locke

New FDA Guidance on AI and Medical Products

Troutman Pepper Locke on

n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

Gardner Law

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

Gardner Law on

US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

Robinson+Cole Manufacturing Law Blog

Chemical “Risk Management Rules” on the Horizon for 2021

The Toxic Substances Control Act (TSCA) has long provided EPA with authority to review new chemical substances in a gatekeeper role as such substances enter U.S. commerce. ...more

Goulston & Storrs PC

Coronavirus: Impact on the Retail Industry

Goulston & Storrs PC on

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

Polsinelli on

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

Foley & Lardner LLP

Coronavirus: Considerations for an Emergency Supply-Chain Response Plan

Foley & Lardner LLP on

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

Goulston & Storrs PC on

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 Manufacturing Law Blog

Unfolding Coronavirus Conditions Present Unprecedented Challenges For Manufacturers

The patchwork of federal, state and local laws addressing leaves of absence, protections of people with disabilities and a manufacturer’s general obligation to provide a safe workplace come head-to-head with public reports of...more

Foley & Lardner LLP

Managing the Commercial Impact of the Coronavirus: An Effective Supply Chain Response Plan

Foley & Lardner LLP on

...The coronavirus (provisionally named SARS-CoV-2, with its disease being named COVID-19) has now been documented in six of the world’s seven continents, with more than 80,000 cases, sparing only Antarctica. Closer to home,...more

Stinson LLP

The Impact of the Coronavirus on the Global Supply Chain

Stinson LLP on

At the end of December, China acknowledged the existence of the coronavirus, and this burgeoning heath crisis is becoming a supply chain problem. China, a major manufacturing hub for materials, products and components being...more

Ballard Spahr LLP

Coronavirus Outbreak Prompts Supply Chain Disruptions

Ballard Spahr LLP on

Now in its third month, the coronavirus outbreak that began in Wuhan, China, has claimed over 2,000 lives and brought one of the world’s most dynamic economies to a near standstill. ...more

Stinson - Government Contracting Matters

Addressing the Impact of the Coronavirus on the Public Sector Supply Chain

At the end of December, China acknowledged the existence of the coronavirus. We don’t know how long it has been around or how many people have actually contracted the virus. We do know the virus has spread at an alarming rate...more

22 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide