For Immediate Release: April 06, 2023 Today, the U.S. Food and Drug Administration announced the final decision to withdraw approval of Makena—a drug that had been approved under the accelerated approval pathway. This drug was approved to reduce the risk …
For Immediate Release: May 04, 2023 Hoy, la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) aprobó Arexvy, la primera vacuna contra el virus sincitial respiratorio (VRS, por sus siglas en inglés) aprobada …
For Immediate Release: April 04, 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Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued draft Guidance for Industry #278, Human User Safety in New and Abbreviated New …
For Immediate Release: March 31, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: This week, the FDA approved three first-time generic animal drugs, bringing additional options to the …
For Immediate Release: March 28, 2023 Español Today, the U.S. Food and Drug Administration released a national strategy outlining actions the agency will take immediately to help ensure one of the nation’s most vulnerable populations continue to have …
For Immediate Release: March 28, 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 an Immediate National Strategy to Increase the Resiliency of the U.S. Infant …
For Immediate Release: March 29, 2023 Español Today, the U.S. Food and Drug Administration approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first naloxone product approved for use …
For Immediate Release: March 24, 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 finalized two guidances: Transition Plan for Medical Devices That Fall Within Enforcement …
For Immediate Release: March 24, 2023 The U.S. Food and Drug Administration today issued draft guidance that provides food manufacturers with recommendations on how and when to use Dietary Guidance Statements on the label of food products to ensure the …
For Immediate Release: March 24, 2023 Today, the U.S. Food and Drug Administration issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics, regarding clinical trial design considerations to support …
For Immediate Release: March 24, 2023 Today, the U.S. Food and Drug Administration proposed changes to the standards of identity (SOIs) for foods that include salt to permit the use of safe and suitable salt substitutes. The proposed rule would help …
For Immediate Release: March 21, 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 completed its second pre-market consultation for a human food made from cultured animal …
For Immediate Release: March 17, 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 issued an emergency use authorization (EUA) for the Cue Mpox (Monkeypox) Molecular Test …
FDA News Release Company Must Stop Marketing Unauthorized Products For Immediate Release: March 17, 2023 Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketed by R.J. …
FDA News Release Manufacturer Must Monitor Consumer Impact; FDA May Withdraw Authorization as Needed to Protect Public Health For Immediate Release: March 16, 2023 Today, the U.S. Food and Drug Administration authorized U.S. Smokeless Tobacco Company’s …
For Immediate Release: March 14, 2023 Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose of the vaccine in children 6 months …
For Immediate Release: March 14, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Yesterday, the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine ( …
For Immediate Release: November 03, 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 announced that its Center for Devices and Radiological Health (CDRH) is seeking …
For Immediate Release: March 10, 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 issued a notice addressing the agency’s COVID-19-related guidance documents, including …
For Immediate Release: October 03, 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, in partnership with the University of Maryland Center of Excellence in Regulatory …
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