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issues that have been uncovered in the past, in April 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to applicants and testing site management on providing recommendations on...more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
Many people experience hearing loss and related hearing issues. To date, to get a hearing aid, people needed a prescription and to see a licensed hearing aid specialist in order to be properly diagnosed and fitted for a...more
In an unprecedented move, the U.S. Food and Drug Administration (FDA or Agency) sent a warning letter to Amazon.com, Inc. (Amazon), a fulfillment house, with respect to distributing over-the-counter (OTC) drug products that...more
On April 28, 2022, the U.S. Food and Drug Administration (FDA) released two proposed rules that would ban menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors such as strawberry and menthol...more
On December 1, 2021, the U.S Food and Drug Administration (FDA) issued warning letters to several companies for marketing vaping products with unproven health claims. In a consumer update, FDA warned consumers that certain...more
On November 16, 2021, U.S. House Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) introduced the highly anticipated Cures 2.0 Act (H.R. 6000). Among other things, this 173-page bipartisan bill contain provisions to...more
On November 16, 2021, the Drug Enforcement Agency (DEA) issued an advance notice of proposed rulemaking, exploring whether or not to create new federal regulations governing the practice of telepharmacy. These regulations...more
What You Need to Know: On December 18, 2020, the Food and Drug Administration issued the second emergency use authorization (“EUA”) for a vaccine for the prevention of COVID-19 in individuals 18 years of age and older. Under...more
What You Need to Know: Late on December 11, 2020, the Food and Drug Administration issued the first emergency use authorization (“EUA”) for a vaccine for the prevention of COVID-19 in individuals 16 years of age and older....more
The FDA’s Vaccines and Related Biological Products Advisory Committee voted 17 to 4 with 1 abstention and 1 no vote that based upon the available scientific evidence, the benefits of the Pfizer and BioNTech’s COVID-19 vaccine...more
On August 6, 2020, President Trump signed an Executive Order (“Order”) to ensure essential medicines, medical countermeasures, and critical inputs are made in the United States. The President recognized that reliable...more
9/10/2020
/ Administrative Procedure Act ,
APIs ,
Department of Health and Human Services (HHS) ,
Essential Drug List ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Personal Protective Equipment ,
Prescription Drugs ,
Public Health Emergency ,
Stafford Act ,
Supply Chain ,
Trade Agreements
As the U.S. continues to struggle to make COVID-19 tests available for symptomatic and asymptomatic individuals, FDA’s position regarding COVID-19 test standards is evolving. The FDA’s pivot is possibly a response to...more
On May 4, 2020, the Food and Drug Administration (FDA) updated its “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) | Immediately in Effect Guidance for Clinical Laboratories, Commercial...more
In the wake of the COVID-19 pandemic, the FDA has sought to expand the availability of needed personal protective equipment (PPE) for the general public and healthcare professionals. Recently, for example, FDA published two...more
4/7/2020
/ 510(k) RTA ,
Affordable Care Act ,
Centers for Disease Control and Prevention (CDC) ,
Department of Health and Human Services (HHS) ,
Enforcement ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicaid ,
Medical Devices ,
Medicare ,
Personal Protective Equipment ,
Prescription Drugs
As the coronavirus outbreak continues to wreak havoc on markets and industries in the U.S. and around the world, businesses are now confronting significant and unique challenges. Successful navigation of these challenges...more
On February 28, 2018, Ethan P. Davis, the Deputy Assistant Attorney General for the Consumer Protection Branch, addressed the life sciences community regarding off-label promotion. In his remarks, Deputy Assistant Attorney...more
3/6/2018
/ Anti-Kickback Statute ,
Attorney General ,
CGMP ,
Department of Justice (DOJ) ,
Enforcement Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Misleading Statements ,
Off-Label Promotion ,
Opioid ,
Pharmaceutical Industry ,
REMS
Fresh off his noticeably smooth confirmation, the new Commissioner of Food and Drugs, Dr. Scott Gottlieb, appeared before Congress last Thursday and unveiled his strategic initiatives and priorities for the Trump Food and...more