Archive for June, 2023

FDA Roundup: June 30, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Thursday, the FDA’s Center for Tobacco…

FDA Provides Update on Proposal for Unified Human Foods Program, including New Model for the Office of Regulatory Affairs

Today, the U.S. Food and Drug Administration is providing an update on its proposal to create a unified Human Foods Program (HFP), which includes a…

FDA Roundup: June 27, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA published new frequently asked…

FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs

Today, the U.S. Food and Drug Administration published a new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs for…

FDA Roundup: June 23, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Thursday, the FDA issued an updated…

FDA Inspection Blitz Leads to More Than 180 Warning Letters to Retailers for the Illegal Sale of Youth-Appealing Elf Bar and Esco Bars E-Cigarettes

Today, the U.S. Food and Drug Administration is announcing it has issued warning letters to 189 retailers for selling unauthorized tobacco products, specifically Elf Bar and…

FDA Approves First Gene Therapy for Treatment of Certain Patients with Duchenne Muscular Dystrophy

Today, the U.S. Food and Drug Administration approved Elevidys, the first gene therapy for the treatment of pediatric patients 4 through 5 years of age…

FDA Launches Pilot Program to Help Reduce Risks Associated with Using Laboratory Developed Tests to Identify Cancer Biomarkers

Today, the U.S. Food and Drug Administration announced a new voluntary pilot program for certain oncology drug products used with certain corresponding in vitro diagnostic…

FDA Roundup: June 20, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA released its report on…

FDA Roundup: June 16, 2023

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the FDA posted information on its…