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Penalties Federal Food Drug and Cosmetic Act (FFDCA)

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

Shipkevich PLLC

CFPB Proposes Order in Massive Action Against Debt Collection Company

Shipkevich PLLC on

On March 23, 2023, the Consumer Financial Protection Bureau (CFPB) has taken action against one of the largest debt collectors in the United States, Portfolio Recovery Associates (PRA), for various violations of law,...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

ArentFox Schiff

Physician Fee Schedule Proposed Rule for 2022 Released: What Pharmaceutical Manufacturers Need to Know

ArentFox Schiff on

The Centers for Medicare & Medicaid Services (CMS) calendar year 2022 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

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

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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