News & Analysis as of

Manufacturers Coronavirus/COVID-19

Goodwin

FDA Platform Technology Draft Guidance Highlights Utility of Obscure Patent Term Extension Provision

Goodwin on

As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...more

Jackson Lewis P.C.

Tips for Recruiting Top Talent in Manufacturing Industry

Jackson Lewis P.C. on

Finding qualified and motivated people to fill open positions is not a new challenge for manufacturers. This task, however, has become harder due to the industry’s rapid rebound post-COVID-19 pandemic and a significant...more

Husch Blackwell LLP

Legal Insights for Manufacturing: Outlook for 2024

Husch Blackwell LLP on

Our downloadable report, Legal Insights for Manufacturing, explores how the business, legal, and regulatory framework is evolving—and will evolve—to address the large generational shifts taking place. This year, our report...more

Paul Hastings LLP

Post-COVID Checkup: Current FDA Due Diligence Considerations

Paul Hastings LLP on

The COVID-19 pandemic highlighted both the incredible promise and challenges for life science companies developing and manufacturing drugs, biological products, and devices that enhance our lives....more

Holland & Knight LLP

Silicon Valley Meets Washington, D.C.: DOD's CSO Authority Is Here to Stay

Holland & Knight LLP on

The U.S. Department of Defense (DOD) has finalized a proposed rule authorizing the acquisition of commercial products and services using general solicitation competitive procedures known as a "commercial solutions opening"...more

Knobbe Martens

FDA Updates Medical Device Shortages List

Knobbe Martens on

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

Jackson Lewis P.C.

What Manufacturers Should Know About the ADA’s Exception for ‘Transitory and Minor’ Impairments

Jackson Lewis P.C. on

Under the Americans With Disabilities Act Amendments Act (ADAAA), employers have a viable defense to an Americans With Disabilities Act (ADA) “regarded as” claim if the impairment in question was “transitory and minor,”...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

GAO Encourages OSHA to Take Action in Meat and Poultry Industry

Recently, the United States General Accounting Office (GAO), which is a nonpartisan agency in the legislative branch, took on oversight of the executive branch agency, Occupational Safety and Health Administration (OSHA). In...more

K2 Integrity

Post-Pandemic Era: Understanding the CHIPS and Science Act of 2022 and Its Impact on the Construction Industry

K2 Integrity on

The COVID-19 pandemic created unprecedented challenges in technology, with the demand for equipment increasing dramatically as the world quickly transitioned into remote operations. During this time, the United States’...more

Hogan Lovells

After the Public Health Emergency: FDA plans to revise COVID-19 EUA policies

Hogan Lovells on

On March 10, 2023, the U.S. Food and Drug Administration (FDA) issued a Notice summarizing which of the agency’s COVID-19-related guidance documents will be rescinded and which will be revised to temporarily remain in effect,...more

Venable LLP

FDA Medical Device Updates to Emergency Use Authorizations and Enforcement Discretion Issued During the COVID-19 Public Health...

Venable LLP on

On March 24, 2023, the Food and Drug Administration (FDA) finalized two transition plan guidance documents for medical devices that either 1) were issued Emergency Use Authorizations (EUAs), or 2) received enforcement...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | January 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity and developments occurring in January 2023, including several criminal and civil enforcement actions related to the federal...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

Adams and Reese LLP

Emerging Trends in Construction Defect/Product Liability for Manufacturers

Adams and Reese LLP on

There are several emerging trends in 2023 concerning construction component manufacturers. 1. Tendering to and/or Adding Subs and Suppliers to Claims/Cases/Matters The most notable trend specific to manufacturers is...more

Jackson Lewis P.C.

Redundancy No Longer Out of Favor in Manufacturing

Jackson Lewis P.C. on

For decades, to increase efficiency and to reduce costs, manufacturers adopted the just-in-time approach, carefully tying manufacturing and staffing capabilities to meet demands without creating surplus. Recent supply-chain...more

Foley & Lardner LLP

Case Law Update: Disputes Relating to Supply Chain Disruptions Hit the Courts

Foley & Lardner LLP on

Over the last two years, the widespread shortages, stoppages, and other disruptions affecting much of the global supply chain have led manufacturers, suppliers, and buyers alike to examine their contract terms for an...more

Wiley Rein LLP

Be Prepared: FDA Signals Transition Countdown for Medical Devices Marketed Under COVID-Era Enforcement Policies, EUAs

Wiley Rein LLP on

On October 17, 2022, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released the list of guidance documents proposed for publication in fiscal year 2023. While it is unclear if...more

Jackson Lewis P.C.

Immigration Delays and How Manufacturers Can Manage Them

Jackson Lewis P.C. on

For employers that hire foreign nationals, whether as local hires already in the country or as transferees from foreign affiliates, immigration processing delays have been exacerbated during the COVID-19 pandemic....more

Foley & Lardner LLP

Foley Manufacturing Update - October 2022

Foley & Lardner LLP on

Key Developments - The most recent article in Foley & Lardner’s Supply Chain Disruption Series shared a number of key takeaways pertaining to accurate and compliant regulatory disclosures in areas including COVID-19...more

Braumiller Law Group, PLLC

"Hot Topics in International Trade - October 2022 - The Semiconductor Industry in México

According to the science of composition, a semiconductor is a material which, when subject to light, heat or a specific electrical voltage may be transformed into a conductor. Semiconductors are used to produce memory...more

Ankura

How to Create a Lean - Yet Secure - Supply Chain in Today’s Uncertain World

Ankura on

A recent survey found that 87% of supply chain professionals plan to invest in resilience in the near future, which is no surprise given the amount of global events which have shocked supply chains recently. Political...more

Jackson Lewis P.C.

Reshoring as a Trending Choice for Manufacturers

Jackson Lewis P.C. on

The COVID-19 pandemic and other global events have forced companies to assess their fundamental operations. Chief among the considerations of U.S. companies in 2022 is how potentially relocating manufacturing can mitigate the...more

Ballard Spahr LLP

Supply Chain Disruptions with Special Guest Chris Mills, CEO of Lion Brand Yarn

Ballard Spahr LLP on

This episode is part of our series “Supply Chain Disruptions,” in which we explore how supply chain issues are affecting businesses everywhere, and when the flow of goods and services may settle into a new normal. This...more

Fisher Phillips

Snapshot on Manufacturing Industry: COVID is Still Relevant

Fisher Phillips on

Welcome to FP Snapshot on Manufacturing Industry, where we take a quick snapshot look at the most significant workplace law developments over the past month with an emphasis on how they impact manufacturers. This edition is...more

ArentFox Schiff

Physician Fee Schedule Proposed Rule for 2023 Released: What Pharmaceutical Manufacturers Need To Know

ArentFox Schiff on

The Centers for Medicare & Medicaid Services (CMS) calendar year 2023 rule proposing changes to payment policies under the Physician Fee Schedule (PFS) and Medicare Part B (the Proposed Rule) will officially be published in...more

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