News & Analysis as of

Department of Justice (DOJ) Regulatory Requirements Manufacturers

Morrison & Foerster LLP

CPSC Issues Weekly Record Level of Product Safety Notices

As noted in our recent client alert, the U.S. Consumer Product Safety Commission (CPSC) continues to aggressively pursue enforcement actions for violations of the Consumer Product Safety Act (CPSA) against foreign...more

Hogan Lovells

Why medical device companies must prioritize compliance with DOJ's Data Security Program

Hogan Lovells on

This regulation is designed to protect U.S. national security by restricting the transfer of bulk sensitive data to foreign entities associated with “countries of concern,” including China, Russia, Iran, North Korea, Cuba,...more

Morgan Lewis

FDA Drug Inspections Post–Workforce Reductions: Potential Implications and Practical Steps Forward

Morgan Lewis on

The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time FDA employees is raising...more

Mintz - Intellectual Property Viewpoints

Regulation, Enforcement, and Associated Challenges of the ENDS Industry: Part I

In 2016, the U.S. Food and Drug Administration (FDA) began regulating all manufacturers, retailers, and distributors of electronic nicotine delivery systems (ENDS) with following the agency’s promulgation of the Final Deeming...more

Husch Blackwell LLP

Legal Insights for Manufacturing: Outlook for 2025

Husch Blackwell LLP on

Intensifying international crises, increasing regulatory burdens, and uncertain macroeconomic conditions have led to an era of caution for manufacturers, but hidden among those challenges are exciting opportunities for...more

Thomas Fox - Compliance Evangelist

Boeing: Accept the Omnibus Monitor Approach

I recently wrote a series of blog posts and articles on why the Department of Justice (DOJ) should think big and go big with a completely new approach to the monitorship for Boeing under its agreement to take a guilty plea....more

Thomas Fox - Compliance Evangelist

To the DOJ: Think Big and Go Big on the Boeing Monitorship

Perhaps the most significant blog post in the compliance arena was penned by Matt Ellis over 10 years ago when he challenged Walmart to “Go Big” on compliance. (They did.) We are now at another inflection point in compliance...more

American Conference Institute (ACI)

[Virtual Event] 3rd Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement - July 21st-22nd, 9:00...

Be part of one-of-a-kind, interactive virtual conference where stakeholders can gather with peers, discuss challenges, and walk away with tailored strategies for overcoming these challenges. As our nation continues with...more

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