Penalties, Food and Drug Administration (FDA), Federal Food Drug and Cosmetic Act (FFDCA)

Are State ENDS Directories Preempted? Federal Courts Are Split

Troutman Pepper Locke on 7/25/2025

Over the past two years, at least 15 states have enacted laws requiring manufacturers of electronic nicotine delivery systems (ENDS) to certify the status of their federal premarket tobacco product applications (PMTAs) in...more

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

Ankura on 4/26/2023

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

PFAS and Food Packaging: The State of Regulation

Perkins Coie on 1/26/2023

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

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

King & Spalding on 10/27/2016

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

"Ranbaxy Resolves Criminal and Civil Charges Through Record Settlement"

Skadden, Arps, Slate, Meagher & Flom LLP on 5/15/2013

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

Penalties › Food and Drug Administration (FDA) › Federal Food Drug and Cosmetic Act (FFDCA)

Are State ENDS Directories Preempted? Federal Courts Are Split

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

PFAS and Food Packaging: The State of Regulation

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

"Ranbaxy Resolves Criminal and Civil Charges Through Record Settlement"

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