Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact the drug, biologics and...more
7/16/2025
/ Biologics ,
Consumer Protection Laws ,
Drug Pricing ,
Enforcement Actions ,
Expedited Approval Process ,
Expedited FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Recalls ,
Proposed Regulation ,
Public Policy ,
Regulatory Agenda ,
Regulatory Reform
The Make America Healthy Again (MAHA) Commission, as established by President Donald Trump's Feb. 13, 2025, Executive Order (EO) 14212, released its inaugural report on May 22, 2025, titled "The MAHA Report: Making Our...more
5/27/2025
/ Artificial Intelligence ,
Chemicals ,
Clinical Trials ,
Environmental Protection Agency (EPA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Supply ,
Information Reports ,
Pesticides ,
Prescription Drugs ,
Public Health ,
Regulatory Reform ,
Toxic Chemicals ,
Trump Administration
In this episode of Holland & Knight's "The Eyes on Washington" podcast series, attorneys Rachel Gartner, Sara Klock, John Vaughan and Michael Werner discuss the evolving landscape of U.S. Food and Drug Administration (FDA)...more
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
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
The U.S. Food and Drug Administration (FDA or Agency) on June 23, 2023, released its first draft guidance concerning design and desired features of clinical trials for psychedelic drugs LSD and MDMA There has been growing...more
On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more
12/17/2018
/ Clinical Laboratories ,
Data Integrity ,
Dietary Supplements ,
Drug Compounding ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Manufacturers ,
New Guidance ,
Opioid ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Regulatory Oversight ,
Stem cells