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Food and Drug Administration (FDA) Penalties

Cozen O'Connor

Nebraska AG Settles Delta-8 Lawsuits Against Four Retailers

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Nebraska AG Mike Hilgers has announced four additional settlements in a series of lawsuits filed against retailers for allegedly selling mislabeled and harmful products containing synthetic THC in violation of Nebraska’s...more

Foley & Lardner LLP

Clinical Research: FDA Issues Draft Guidance on Informed Consent

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The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more

Harris Beach PLLC

HHS Office of Inspector General October 2023 Enforcement Activity

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The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more

Davis Wright Tremaine LLP

Stay ADvised: Brand Protection & Advertising Law News - August 2023 - 2

Kardashian Kopycat? Energy Drink Company Claims Competitor Stole Kim's Copyrighted Look - The Instagram posts look nearly identical, in a blink-and-you'll-miss-the-difference kind of way—or so says the complaint filed by...more

Ankura

FDA Authorized to Establish New Cybersecurity Standards for Medical Devices: What it Means for Industry

Ankura on

On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...more

Hinch Newman LLP

Roundup of FTC Consumer Protection Matters of Interest to Digital Advertisers: March 2023

Hinch Newman LLP on

In March 2023, the Federal Trade Commission announced a number of consumer protection actions involving data privacy, COVID health claims, a robocall debt relief pitch scheme, and alleged harmful noncompete restrictions. The...more

Perkins Coie

PFAS and Food Packaging: The State of Regulation

Perkins Coie on

Introduction  In the absence of comprehensive federal legislation, states have started to regulate per- and polyfluoroalkyl substances (PFAS) in food packaging. This Update provides an overview of the current regulatory...more

Oberheiden P.C.

6 Frequently Asked Questions with Lab Defense Attorney Nick Oberheiden

Oberheiden P.C. on

Clinical laboratories have come under increased scrutiny in the past few years, especially those that deal with COVID-19 testing or drug testing. These federal investigations can be surprising and confusing for lab...more

Foley & Lardner LLP

Key Takeaways from USDA’s Interim Hemp Production Rule

Foley & Lardner LLP on

On October 31, 2019 the U.S. Department of Agriculture (USDA) published an Interim Final Rule (84 FR 58522) establishing the U.S. Domestic Hemp Production Program and outlining a regulatory framework for monitoring hemp...more

King & Spalding

HHS Issues Final Rule that Expands the Requirements for Disclosure of Clinical Trial Data to ClinicalTrials.gov

King & Spalding on

On September 21, 2016, the Department of Health and Human Services (HHS) published a final rule that greatly expands the information that sponsors of “applicable drug clinical trials” and “applicable device clinical trials”...more

McCarter & English, LLP

Health Law Insights - Issue 12

CMS Proposes Bundled Payments for Cardiac Care - In its most recent effort to hasten Medicare’s transformation from a fee-for-service payment model to a value-based payment model, the Centers for Medicare & Medicaid...more

Manatt, Phelps & Phillips, LLP

Health Update - September 2015

Latest Healthcare False Claims Act Roundup and Top 3 Best Practices to Reduce Exposure - As the legal landscape in healthcare becomes increasingly complex, healthcare companies that receive federal program funds face...more

Skadden, Arps, Slate, Meagher & Flom LLP

"Ranbaxy Resolves Criminal and Civil Charges Through Record Settlement"

Executive Summary - On May 13, 2013, generic drug manufacturer Ranbaxy USA Inc. (Ranbaxy), a subsidiary of Indian generic drug manufacturer Ranbaxy Laboratories Limited, pled guilty to seven felony charges as part of a...more

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