For Immediate Release: November 17, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, to mark the 15th anniversary of the FDA foreign offices, the FDA published an interview with …
For Immediate Release: November 16, 2023 Yesterday, the U.S. Food and Drug Administration announced that a dietary supplement distributor, manufacturer, and two executives have been ordered by a federal court to stop producing and selling their products …
FDA News Release Today’s Action also Opens the 510(k) Pathway for Other Tests for These Infections with At-Home Sample Collection For Immediate Release: November 15, 2023 Today, the U.S. Food and Drug Administration granted marketing authorization to …
For Immediate Release: November 15, 2023 Today, the U.S. District Court for the District of Arizona entered a consent decree of permanent injunction ordering Smart Women’s Choice, Inc., an Arizona-based company, and Jennifer A. Richard, its chief executive …
For Immediate Release: November 14, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA updated the advisory for the Investigation of Elevated Lead Levels in Cinnamon …
For Immediate Release: October 31, 2023 Today, the U.S. Food and Drug Administration approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. Wezlana, like Stelara, is …
For Immediate Release: October 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 Center for Tobacco Products (CTP) Director Brian King published a statement summarizing …
For Immediate Release: October 26, 2023 As part of the U.S. Food and Drug Administration’s commitment to protecting public health, the agency is advising the public, including healthcare providers, of the possible risks that products containing live …
For Immediate Release: October 24, 2023 Today, the U.S. Food and Drug Administration approved Tibsovo (ivosidenib) for the treatment of adult patients with relapsed or refractory (R/R) myelodysplastic syndromes (MDS) with an isocitrate dehydrogenase-1 ( …
For Immediate Release: October 24, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Friday, the FDA approved Medtronic’s Aurora EV-ICD System for the treatment of patients who have …
For Immediate Release: October 19, 2023 Statement From: James Jones Deputy Commissioner for Human Foods - Food and Drug Administration Earlier this year, U.S. Food and Drug Administration Commissioner Robert M. Califf, M.D. laid out a bold vision to …
For Immediate Release: October 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’s The Center for Drug Evaluation and Research (CDER) announced that the center is …
For Immediate Release: October 13, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: The FDA Oncology Center of Excellence (OCE) in conjunction with the European Medicines Agency (EMA) …
For Immediate Release: October 11, 2023 Today, the U.S. Food and Drug Administration announced the creation of a new Digital Health Advisory Committee to help the agency explore the complex, scientific and technical issues related to digital health …
For Immediate Release: September 29, 2023 Today, the U.S. Food and Drug Administration granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test that can help detect hundreds of genetic variants …
For Immediate Release: September 29, 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 a video titled “Importing FDA-Regulated Products: Human Foods” that provides …
For Immediate Release: September 29, 2023 Today, the U.S. Food and Drug Administration announced a proposed rule regarding laboratory developed tests, or LDTs, which play an important role in healthcare. The rule is aimed at helping to ensure the safety …
FDA News Release La guía preliminar brinda ejemplos de formas en que los fabricantes pueden minimizar o prevenir en grsn medida el contacto cruzado con alérgenos y alérgenos no declarados For Immediate Release: September 26, 2023 English Hoy la …
For Immediate Release: September 26, 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 the final guidance Cybersecurity in Medical Devices: Quality System …
FDA News Release Draft Guidance Provides Examples of Ways Manufacturers Can Significantly Minimize or Prevent Allergen Cross-Contact and Undeclared Allergens For Immediate Release: September 26, 2023 Today, the U.S. Food and Drug Administration announced …
