“By streamlining the biosimilar development process and helping advance interchangeability, we can achieve massive cost reductions for advanced treatments for cancer, autoimmune diseases, and rare disorders affecting millions...more
Life sciences companies aggrieved by competitor activity believed to be in violation of the Federal, Food, Drug, and Cosmetic Act (FDCA) have been consistently unsuccessful in challenging these activities in court – this...more
On September 9, 2025, the U.S. Department of Health & Human Services (HHS) and the U.S. Food & Drug Administration (FDA) issued thousands of letters warning pharmaceutical companies to remove “misleading” advertisements and...more
With the dissolution of the U.S. Department of Justice’s Consumer Protection Branch set to occur by Sept. 30, a vital question that remains to be fully answered is who will be responsible for litigation matters typically...more
8/18/2025
/ Consumer Protection Laws ,
Department of Justice (DOJ) ,
Deregulation ,
Enforcement Actions ,
Executive Orders ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Opioid ,
Popular ,
State Attorneys General ,
Trump Administration
Call to Action. In a letter dated July 9, 2025, the U.S. Food and Drug Administration (FDA) issued a clear call to action for manufacturers, distributors, and retailers of infant formula, baby food, and children’s food...more
On May 21, 2025, the Connecticut Office of the Attorney General released a statement and sent letters to Connecticut weight loss clinics, med spas, medical practices and other businesses regarding allegedly or potentially...more
6/6/2025
/ Consumer Protection Laws ,
Drug Compounding ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Health Care Providers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements ,
State Attorneys General ,
Unfair or Deceptive Trade Practices
A Texas judge for the U.S. District Court for the Eastern District of Texas issued a ruling on March 31, 2025, to vacate and set aside, in its entirety, the U.S. Food and Drug Administration’s (FDA) Final Rule titled Medical...more
4/3/2025
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Judicial Authority ,
Medical Devices ,
Regulatory Authority ,
Regulatory Requirements ,
Vacated
On March 5, 2025, one U.S. District Court ruled unequivocally in the Food & Drug Administration’s (FDA) favor in the case, Outsourcing Facilities Ass’n, et. al. v. U.S. Food and Drug Admin., et. al., 4:24-cv-0953-P, slip op.,...more
3/13/2025
/ Appeals ,
Drug Compounding ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry ,
Pharmacies ,
Preliminary Injunctions ,
Prescription Drugs ,
Regulatory Requirements
On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more
1/16/2025
/ Artificial Intelligence ,
Clinical Trials ,
Compliance ,
Digital Health ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Machine Learning ,
Patents ,
Pharmaceutical Industry ,
Popular ,
Regulatory Requirements ,
Risk Management ,
Trade Secrets
On December 4, 2024, the U.S. Food & Drug Administration (FDA) released its Marketing Submissions for a Predetermined Change Control Plan (PCCP) for Artificial Intelligence-Enabled Device Software Functions (AI-DFS) final...more
On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a Declaratory Order reevaluating and re-confirming that the tirzepatide drug shortage has been resolved. This order revoked and replaced FDA’s October...more
On December 17, the U.S. Food and Drug Administration (FDA) issued Warning Letters to five companies offering various GLP-1 products, including Semaglutide, Tirzepatide, Retatrutide, Cagrilintide, Mazdutide, Survodutide, and...more
What Are ADCs and Why Are They Growing?
Over the past few years economic headwinds have resulted in fewer deals, with companies and private equity firms alike reassessing where to spend money. But one portion of the...more
Brand companies who own GLP-1 products have been pushing the Food and Drug Administration (FDA) to limit their compounding. On August 28, 2024, Eli Lilly and Company submitted a nomination to request that its GLP-1 product,...more
Less than a week after the U.S. Food & Drug Administration (FDA) determined that the shortage of the tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been “resolved” and removed from the FDA’s shortage...more
On October 2, 2024, the U.S. Food and Drug Administration (FDA) determined the shortage of the tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been “resolved”. The tirzepatide injection had appeared...more
As we make further strides into 2024, the fashion, apparel & beauty landscape continues its dynamic evolution, marked by opportunities and challenges. Consumer preferences, technological breakthroughs, geopolitical shifts,...more
5/17/2024
/ Copyright ,
Cosmetics ,
Deep Fake ,
Fashion Industry ,
Food and Drug Administration (FDA) ,
FTC Act ,
Greenwashing ,
Licensing Rules ,
Luxury Goods ,
Recycling ,
Right of Publicity ,
Royalties ,
Trademarks
Given data integrity issues that have been uncovered in the past, in April 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to applicants and testing site management on providing recommendations on...more
On Friday, January 5, 2024, in a major policy shift, the U.S. Food & Drug Administration (FDA) authorized Florida’s Agency for Health Care Administration’s plan to purchase medicines in bulk for its Medicaid programs,...more
In the effort to enhance product quality and the integrity of the infant formula supply chain after contamination resulted in the 2022 baby formula shortage, Congress and the FDA took steps to ensure that infants and parents...more
The listing of many types of patents in the FDA’s Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) is fairly straightforward. Patents covering the approved drug product (active pharmaceutical...more
The labeling of biosimilar products as “interchangeable” may be important in order to gain acceptance and use in the medical community. This article provides important information regarding revised FDA labeling guidance for...more
The fashion industry has experienced another year of continued change driven by consumer trends, innovation in technology, geopolitical and public health issues, and legal developments, and we don’t anticipate that stopping...more
4/18/2023
/ Blockchain ,
Class Action ,
Copyright Infringement ,
Fashion Industry ,
Jack Daniels Properties Inc v VIP Products LLC ,
Lanham Act ,
Louis Vuitton ,
Mexico ,
Non-Fungible Tokens (NFTs) ,
Petition for Writ of Certiorari ,
PFAS ,
SCOTUS ,
Supply Chain ,
Trademarks
On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act, 2023, which includes the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). MoCRA significantly changes the current regulatory...more
Congress recently introduced a bill that could expand access to therapeutic psychedelics that are designated as Breakthrough Therapies. These products are potentially useful in treating addiction, depression, post-traumatic...more