The U.S. Food and Drug Administration (FDA or Agency) rejected the new drug application (NDA) for a drug marketing approval submitted by Lykos Therapeutics Inc. (Lykos) for its psychedelic MDMA drug on Aug. 9, 2024. Lykos...more
Recent congressional activity highlights the changing environment for cannabis regulation. Specifically, U.S. Congress is moving forward with legislation that will change the regulation of hemp-derived products. The industry...more
7/29/2024
/ Appropriations Bill ,
Cannabis Products ,
Congressional Committees ,
Controlled Substances Act ,
DEA ,
Department of Agriculture ,
Farm Bill ,
Hemp ,
Proposed Amendments ,
Proposed Legislation ,
THC ,
USDA
The U.S. Supreme Court on June 13, 2024, unanimously ruled that plaintiffs did not have legal standing to challenge the U.S. Food and Drug Administration's (FDA) actions to establish dosing and availability requirements for...more
In this episode of "The Eyes on Washington Podcast," Public Policy & Regulation attorneys Michael Werner, Sara Klock, Joshua Odintz and Ed Perlmutter discuss the proposed rule by the U.S. Drug Enforcement Administration (DEA)...more
The U.S. Drug Enforcement Administration (DEA) on May 16, 2024, issued a proposed rule to move marijuana from its current classification as a Schedule I drug to a Schedule III drug, thereby loosening federal DEA restrictions....more
In the latest episode of Holland & Knight's Public Policy & Regulation Group "Eyes on Washington" podcast series, Healthcare & Life Sciences attorney Michael Werner and Sara Klock examine pivotal shifts in U.S. Food and Drug...more
The U.S. Food and Drug Administration (FDA or Agency) announced on April 29, 2024, in a forthcoming and long-awaited final rule that laboratory developed tests (LDTs) will be regulated as medical devices....more
In the next episode of the "Legal Bites Podcast" series, Food and Beverage Litigation Team leader Nathan Adams and Practice Development Manager Kristina Merritt speak with Public Policy & Regulation attorney Sara Klock, who...more
In this episode of the "Eyes on Washington" podcast series by Holland & Knight's Public Policy & Regulation Group, Healthcare and Life Sciences attorneys Michael Werner and Sara Klock discuss recent developments in marijuana,...more
The bipartisan leadership of the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor and Pensions released a formal Request for Information (RFI) to the public on July 27, 2023, to...more
The U.S. Food and Drug Administration (FDA or Agency) on June 23, 2023, released its first draft guidance concerning design and desired features of clinical trials for psychedelic drugs LSD and MDMA There has been growing...more
The FDA announced on Feb. 28, 2023, it will move cosmetics regulation out of the CFSAN and into the OCS. The move stems from the FDA's broader initiative to reorganize food safety regulation and oversight, as well as allow...more
U.S. Food and Drug Administration (FDA) Commissioner Robert Califf on Jan. 31, 2023, announced a proposed restructuring of the agency's Human Foods Program in an effort to improve coordination among the FDA offices. These...more
The U.S. Food and Drug Administration (FDA) recently announced its plan to provide medical device manufacturers 180 days to secure marketing authorization or clearance for medical devices that have been marketed under special...more
More than six months into the pandemic, there is still no easy or definitive answer to the question many retailers are asking about whether there is coverage for their business interruption losses related to COVID-19....more
10/14/2020
/ Agricultural Sector ,
Antitrust Violations ,
Business Interruption ,
Class Action ,
Commercial Insurance Policies ,
Coronavirus/COVID-19 ,
Dismissals ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
FSMA ,
Health Claims ,
NLRA ,
NLRB ,
Notice Requirements ,
OSHA ,
Putative Class Actions ,
Reversal ,
Tip Credit ,
Unfair Competition ,
Wage and Hour
The U.S. Food and Drug Administration (FDA) has officially launched the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH) to expand the agency's activities in furtherance of its...more
Issues relating to liability for pharmaceutical, personal protective equipment (PPE) and diagnostic test businesses as well as for physicians and healthcare personnel in the coronavirus (COVID-19) context remains a salient...more
In response to the COVID-19 pandemic and the need for more diagnostic testing, the U.S. Food and Drug Administration (FDA) has developed several pathways for manufacturers and developers of COVID-19 diagnostic tests to...more
The widely reported shortages of Personal Protective Equipment (PPE), including masks and gowns, across the United States have led to the importation, distribution and use of PPE manufactured overseas. In particular, many...more
The U.S. Food and Drug Administration (FDA) has issued several final guidance documents to assist manufacturers developing medical products in response to the coronavirus (COVID-19) pandemic. While some are published as...more
The U.S. Food and Drug Administration (FDA) has issued a new guidance for novel coronavirus (COVID-19) molecular diagnostics tests developed and used in certain laboratories. The guidance, issued on Feb. 29, 2020, is designed...more
In the midst of expanded development and marketing of products containing cannabis and cannabis-derived compounds, President Donald Trump's FY 2021 proposed budget includes an additional $5 million for the U.S. Food and Drug...more
2/12/2020
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Congressional Committees ,
Dietary Supplements ,
Enforcement Programs ,
Federal Budget ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Hemp ,
Information Reports ,
Marijuana-Infused Edibles ,
Regulatory Agenda ,
Trump Administration
On November 25, 2019, the U.S. Food and Drug Administration (FDA) announced that it issued warning letters to several companies for illegally selling products containing cannabidiol (CBD). The FDA also published a revised...more
The U.S. Department of Agriculture (USDA) has issued an Interim Final Rule (IFR) for the establishment of a domestic hemp production program. By publishing the rule in the form of an IFR, USDA is able to issue guidance before...more
Wage and Hour -
80/20 Rule Still Followed in Some Parts -
The U.S. Department of Labor (DOL) issued guidance doing away with the so-called "80/20 rule" in November 2018. District courts have greeted the new guidance...more
7/11/2019
/ Americans with Disabilities Act (ADA) ,
Auer Deference ,
Beverage Manufacturers ,
Cannabidiol (CBD) oil ,
Class Action ,
Department of Labor (DOL) ,
Dietary Supplements ,
Duty to Defend ,
Employer Liability Issues ,
Fair Labor Standards Act (FLSA) ,
FBI ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
GrubHub ,
Hiring & Firing ,
Liquor Control Acts ,
New Guidance ,
Price-Fixing ,
Putative Class Actions ,
Securities Litigation ,
Wage and Hour ,
Wine & Alcohol