FDA

FDA

FDA Cracks Down on Dangerous 7-OH Opioid Products

For Immediate Release:  July 29, 2025The U.S. Food and Drug Administration today is taking a bold step to protect Americans from dangerous, illegal opioids by recommending a scheduling action to control certain 7-hydroxymitragynine (also known as 7-OH ) products under the Controlled Substances Act (CSA). The FDA is specifically targeting

FDA

FDA Supports State Plans to Make Prescription Drugs Cheaper

For Immediate Release:  May 21, 2025The U.S. Food and Drug Administration is continuing to take steps to help state importation programs provide safe, effective and more affordable drugs for American patients, as part of its efforts to implement Executive Order Lowering Drug Prices by Once Again Putting Americans First.

FDA

FDA Steps In: Fluoride Drugs for Kids to Be Removed

For Immediate Release:  May 13, 2025The U.S. Food and Drug Administration (FDA) today announced that it is initiating action to remove concentrated ingestible fluoride prescription drug products for children from the market. Unlike toothpaste with fluoride or fluoride rinses, these products are swallowed and ingested by infants and toddlers.

FDA

Product Recalls Explained: What You Need to Know

What Is a Recall? A recall is an action taken by a company to correct or remove from the market an FDA regulated product that violates U.S. laws and regulations. Recalls may be initiated voluntarily by a company, or at the request of the FDA. Recalls are important because

FDA

FDA New Update: New Treatments, Safety Alerts, and Medical Advancements

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FDA

FDA News Update: Nationwide Shift to Natural Food Dyes Begins

For Immediate Release:  April 22, 2025The U.S. Department of Health and Human Services and U.S. Food and Drug Administration (FDA) today announced a series of new measures to phase out all petroleum-based synthetic dyes from the nation’s food supply—a significant milestone in the administration’s broader

FDA

FDA News Update: Rare Disease Videos, Cabometyx Approval, and Seafood Safety

For Immediate Release:  March 28, 2025Today, 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 Learning and Education to ADvance and Empower Rare Disease Drug Developers initiative published two new videos titled “Understanding the Importance of

FDA

FDA News Update: FDA Plans to End Animal Testing Requirement for Some New Drugs

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FDA

FDA News Update: FDA Approves Novel Treatment for Hemophilia A or B, with or without Factor Inhibitors

<div class="inset-column"> <dl class="lcds-description-list--grid"> <dt class="cell-1_1">For Immediate Release:</dt> <dd class="cell-2_1"><time datetime="2025-03-28T18:15:00Z">March 28, 2025</time&

FDA

FDA News Update: Martin A. Makary, M.D., M.P.H., Sworn in as FDA Commissioner

<div class="inset-column"> <dl class="lcds-description-list--grid"> <dt class="cell-1_1">For Immediate Release:</dt> <dd class="cell-2_1"><time datetime="2025-04-01T13:00:00Z">April 01, 2025</time&

FDA

FDA Update: New Tool Shows Chemical Contaminant Levels in Food for Greater Transparency

For Immediate Release:  March 20, 2025Today, under the leadership of U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr., the U.S. Food and Drug Administration unveiled the Chemical Contaminants Transparency Tool (CCT Tool), an online searchable database providing a consolidated list of contaminant levels (e.

FDA

FDA Update: New Kidney Drug Approved, Medical Device Alert Issued, and Colonoscopy Cleaner AuthorizedFDA Roundup: March 21, 2025

For Immediate Release:  March 21, 2025Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: * On Thursday, the FDA approved Fabhalta (iptacopan) for the treatment of adults with complement 3 glomerulopathy (C3G) to reduce proteinuria. C3G is a rare disease that