Manufacturer Liability, Enforcement Actions

Tennessee AG Sues More Than 20 PFAS Manufacturers

Troutman Pepper on 7/21/2023

Tennessee AG Jonathan Skrmetti is suing more than 20 per- and polyfluoroalkyl substance (PFAS) manufacturers, including 3M and DuPont, seeking injunctive and monetary relief under the state’s public nuisance and uniform...more

FDA Warning Letter Response Strategies (Step-By-Step)

Oberheiden P.C. on 3/2/2022

FDA Warning letters can be harbinger of formal civil and criminal investigations. If your business receives such a notice of non-compliance from the FDA, you should immediately contact an experienced FDA defense attorney....more

Made in USA, Part Two – How Far Back Do You Have to Look?

BakerHostetler on 1/20/2022

Prior to the new year, we blogged about how the Federal Trade Commission’s (Commission) decision to codify its Made in USA (MUSA) guidance into a rule – and the accompanying threat of civil penalties – makes it all the more...more

Update on FDA’s Comprehensive Regenerative Medicine Policies and Enforcement Activities

Mintz - Health Care Viewpoints on 5/8/2019

Since our 2018 year-end post on the busy FDA regulatory agenda, we are nearing the halfway mark of the “grace period” the Agency has extended for certain regenerative medicine product developers to come into compliance by...more

A Client’s Guide to FDA Recalls

Akin Gump Strauss Hauer & Feld LLP on 4/11/2019

Recent FDA Recall Highlights & Developments - • The agency finalized Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Guidance for Industry and FDA Staff, providing recommendations regarding the...more

HRSA to Enforce 340B Program Oversight of Drug Manufacturers Next Year and Share 340B Ceiling Prices with Covered Entities

Baker Donelson on 12/13/2018

Two recent announcements by the Health Resources and Services Administration (HRSA) highlight the agency's plans for increased oversight in the next year of drug manufacturers under the 340B drug pricing program and...more

Internet of Things Part 2: Dogs, Cameras, and Cybersecurity

Jackson Walker on 7/6/2018

I recently purchased an Internet Protocol (IP) camera to monitor my dog, Ruben, during those times that he has free reign of the house. Since “RubenCam” has been online, I’m not sure he has been any less rambunctious, but I’m...more

The Crackdown Continues: FDA Takes Action Against Company And Its Autologous Stem Cell Product, Alleging Significant Safety...

Hogan Lovells on 1/8/2018

Last week, FDA published a January 3, 2018 Warning Letter issued to American CryoStem for marketing Atcell—an adipose tissue derived stem cell product—without FDA approval and for several drug current Good Manufacturing...more

Manufacturer Liability › Enforcement Actions

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