Given the continued challenges in policing the burgeoning ENDS marketplace, as previously discussed in Part I of this article, in mid-2024 FDA and DOJ announced the establishment of a federal multi-agency task force to combat...more
4/16/2025
/ Civil Monetary Penalty ,
Customs and Border Protection ,
Department of Justice (DOJ) ,
E-Cigarettes ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Intellectual Property Litigation ,
International Trade Commission (ITC) ,
Patent Infringement ,
Patents ,
SCOTUS ,
Tobacco
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
We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests (LDTs) as medical devices and to phase...more
3/14/2025
/ Clinical Laboratory Testing ,
Compliance ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Healthcare ,
Medical Devices ,
Regulation ,
Regulatory Requirements ,
Risk Management
The Food and Drug Administration (FDA) published its final rule on laboratory developed tests (LDTs) in the Federal Register on May 6, marking a watershed moment in the agency’s arduous decade-plus-long journey toward winding...more
In its first exercise of a newly granted authority, the Federal Trade Commission (FTC or the Commission) on April 15, 2021 charged a St. Louis-based chiropractor and his company (the Defendants) with violating the COVID-19...more
In addition to the incredible work of agency scientists and reviewers to get the first COVID-19 vaccines authorized for emergency use in December (as we covered in Part 2 of our year-end post), the Food and Drug...more
12/28/2020
/ Biologics ,
Center for Biologics Evaluation and Research (CBER) ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
Enforcement Actions ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Over The Counter Drugs (OTC) ,
Prescription Drugs ,
Vaccinations
Two weeks ago, on March 9, the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) sent warning letters to seven companies that allegedly made false or deceptive claims about their products’ ability to...more
Continuing progress on the initiatives announced in its Biosimilars Action Plan in July 2018, the Food and Drug Administration (FDA) released information about several important biosimilar-related actions on February 3, 2020....more
2/5/2020
/ Biologics ,
Biosimilars ,
Competition ,
Draft Guidance ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Joint Statements ,
Pharmaceutical Industry ,
Public Health ,
Public Workshops
To anyone who has been following government enforcement and private litigation trends related to the over-the-counter (OTC) homeopathic drug industry over the past several years, the Food and Drug Administration’s (FDA)...more
10/28/2019
/ Draft Guidance ,
Enforcement Actions ,
Enforcement Guidance ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Over The Counter Drugs (OTC) ,
Over-the-Counter Sales ,
Pharmaceutical Industry ,
Public Comment ,
Regulatory Agenda ,
Regulatory Standards
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
5/8/2019
/ Bad Actors ,
Distributors ,
Enforcement Actions ,
FDA Warning Letters ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
FTC Act ,
Manufacturer Liability ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Agenda
In a major public move that has been long-awaited by proponents of evidence-based stem cell science, FDA Commissioner Scott Gottlieb issued a lengthy statement on August 28, 2017 “on the FDA’s new policy steps and enforcement...more
9/5/2017
/ 21st Century Cures Act ,
Drug Safety ,
Enforcement Actions ,
Expedited Approval Process ,
FDA Commissioner ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Regenerative Medicine ,
Search & Seizure ,
Stem cells
As we enter a new era in which executive agencies are headed by President Trump, we are also faced with many other transformative changes that will affect FDA-regulated entities in a significant and lasting way. This post...more
Over the past year, significant regulatory changes began to take shape that will have lasting effects on the laboratory industry for years to come. After publishing draft guidance regarding the regulation of laboratory...more
12/31/2015
/ Aetna ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
CIGNA ,
CLIA ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
OIG ,
PAMA ,
Stark Law