FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on July 10, 2025 - 12:36 GMT

FDA Embraces Radical Transparency by Publishing Complete Response Letters

For Immediate Release: July 10, 2025 The U.S. Food and Drug Administration (FDA) today published more than 200 decision letters, known as complete response letters (CRLs). The CRLs were issued in response to applications submitted to the FDA for approval …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 9, 2025 - 20:01 GMT

FDA Encourages Industry Leaders to Streamline, Enhance Product Recall Communications to Safeguard Foods for Infants and Children

FDA News Release Stronger, More Transparent Notices Increase Public Safety For Immediate Release: July 09, 2025 The U.S. Food and Drug Administration today called for increased attention to product recall communications from industry leaders involved in …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 8, 2025 - 09:32 GMT

FDA Announces New FDA PreCheck Program to Boost U.S. Drug Manufacturing

For Immediate Release: August 07, 2025 The U.S. Food and Drug Administration today announced FDA PreCheck, a new program to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 27, 2025 - 20:52 GMT

FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor CAR T cell ...

FDA News Release Agency determines the safety and effectiveness of these immunotherapies can be assured without a REMS For Immediate Release: June 27, 2025 The U.S. Food and Drug Administration announced today that it has eliminated the Risk Evaluation and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 18, 2025 - 22:16 GMT

FDA Halts New Clinical Trials That Export Americans’ Cells to Foreign Labs in Hostile Countries for Genetic Engineering

For Immediate Release: June 18, 2025 The U.S. Food and Drug Administration (FDA) today announced an immediate review of new clinical trials that involve sending American citizens’ living cells to China and other hostile countries for genetic engineering …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 17, 2025 - 15:18 GMT

FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests

For Immediate Release: June 17, 2025 The U.S. Food and Drug Administration today announced its Commissioner’s National Priority Voucher (CNPV) program to enhance the health interests of Americans. The new voucher may be redeemed by drug developers to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 11, 2025 - 13:49 GMT

FDA Awards Second Batch of National Priority Vouchers

For Immediate Release: November 06, 2025 The U.S. Food and Drug Administration today announced six additional awardees under the Commissioner’s National Priority Voucher (CNPV) pilot program. This second cohort brings the total number of voucher recipients …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 22, 2025 - 17:46 GMT

FDA Takes Action to Address Data Integrity Concerns with Two Chinese Third-Party Testing Firms

For Immediate Release: May 22, 2025 The U.S. Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) issued General Correspondence Letters to two third-party testing companies in China after discovering data that was …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 22, 2025 - 14:48 GMT

FDA and CBP Seize Nearly $34 Million Worth of Illegal E-Cigarettes During Joint Operation

For Immediate Release: May 22, 2025 The U.S. Food and Drug Administration (FDA) today announced the seizure of nearly two million units of unauthorized e-cigarette products in Chicago, with an estimated retail value of $33.8 million. The seizures, which …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 21, 2025 - 13:31 GMT

FDA takes steps to enhance state importation programs to help lower prescription drug prices

For Immediate Release: May 21, 2025 The 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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 15, 2025 - 21:28 GMT

FDA Advances Robust, Transparent Post-Market Chemical Review Program to Keep Food Supply Safe and Healthy

For Immediate Release: May 15, 2025 The U.S. Food and Drug Administration today is taking a major step to increase transparency and ensure the safety of chemicals in our food. The agency is launching a stronger, more systematic review process for food …

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Published on May 13, 2025 - 15:19 GMT

FDA Begins Action To Remove Ingestible Fluoride Prescription Drug Products for Children from the Market

For Immediate Release: May 13, 2025 The 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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 13, 2025 - 13:55 GMT

HHS, FDA Issue RFI on Deregulatory Plan to Lower Costs and Empower Providers

For Immediate Release: May 13, 2025 The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) today announced the launch of a public Request for Information (RFI) to identify and eliminate outdated or …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 11, 2025 - 13:44 GMT

FDA Warns Companies Over Illegal Marketing of Botox and Related Products

For Immediate Release: November 05, 2025 The U.S. Food and Drug Administration issued 18 warning letters to owners of websites illegally marketing unapproved and misbranded botulinum toxin products, commonly called Botox. The agency is aware of adverse …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 9, 2025 - 17:15 GMT

FDA and NIH Announce Innovative Joint Nutrition Regulatory Science Program

For Immediate Release: May 09, 2025 Today, the U.S. Food and Drug Administration and the National Institutes of Health (NIH) announced a new, joint innovative research initiative that will serve as a key element in fulfilling U.S. Department of Health and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 9, 2025 - 14:49 GMT

FDA Approves Three Food Colors from Natural Sources

For Immediate Release: May 09, 2025 The U.S. Food and Drug Administration today announced it granted three new color additive petitions that will expand the palette of available colors from natural sources for manufacturers to safely use in food. The FDA …

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Published on May 8, 2025 - 15:15 GMT

FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline

For Immediate Release: May 08, 2025 In a historic first for the agency, FDA Commissioner Martin A. Makary, M.D., M.P.H., today announced an aggressive timeline to scale use of artificial intelligence (AI) internally across all FDA centers by June 30, 2025, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 6, 2025 - 15:32 GMT

FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities

For Immediate Release: May 06, 2025 Today, the U.S. Food and Drug Administration announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products …

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Published on April 22, 2025 - 20:41 GMT

HHS, FDA to Phase Out Petroleum-Based Synthetic Dyes in Nation’s Food Supply

For Immediate Release: April 22, 2025 The 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 …

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Published on April 17, 2025 - 19:08 GMT

FDA Commissioner Makary Announces New Policy on Individuals Serving on FDA Advisory Committees

For Immediate Release: April 17, 2025 In keeping with U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr.’s promise to carry out the Department’s work with “radical transparency” and mitigate perceived industry influence and …

Distribution channels: Healthcare & Pharmaceuticals Industry