FDA Press Releases

• Published on September 29, 2023 - 22:19 GMT

  

  FDA Grants First Marketing Authorization for a DNA Test to Assess Predisposition for Dozens of Cancer Types

  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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 29, 2023 - 20:18 GMT

  

  FDA Roundup: September 29, 2023

  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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 29, 2023 - 16:39 GMT

  

  FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies

  For Immediate Release: September 29, 2023 Today, the U.S. Food and Drug Administration is taking steps to help further accelerate the development of novel drug and biological products for rare diseases. The agency is announcing the opportunity for a …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 29, 2023 - 13:15 GMT

  

  FDA Proposes Rule Aimed at Helping to Ensure Safety and Effectiveness of Laboratory Developed Tests

  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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 28, 2023 - 16:06 GMT

  

  FDA Seeks Fines Against 22 Retailers for Selling Illegal Youth-Appealing E-Cigarettes

  For Immediate Release: September 28, 2023 The U.S. Food and Drug Administration issued complaints for civil money penalties (CMPs) against 22 retailers for the illegal sale of Elf Bar/EB Design e-cigarettes, a popular youth-appealing brand. The FDA …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 27, 2023 - 12:42 GMT

  

  La guía preliminar de la Admistración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) podría dar ...

  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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 26, 2023 - 19:50 GMT

  

  FDA Roundup: September 26, 2023

  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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 26, 2023 - 14:24 GMT

  

  FDA Draft Guidance Could Result in Safer Food Options for People with Allergies to Sesame, Other Food Allergens

  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 …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 22, 2023 - 20:22 GMT

  

  FDA Roundup: September 22, 2023

  For Immediate Release: September 22, 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 the revised, draft guidance Formal Meetings Between the FDA and Sponsors …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 19, 2023 - 20:13 GMT

  

  FDA Roundup: September 19, 2023

  For Immediate Release: September 19, 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 informed the public in the Prostate Cancer Symptoms, Tests and Treatments Consumer …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 15, 2023 - 20:07 GMT

  

  FDA Roundup: September 15, 2023

  For Immediate Release: September 15, 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 draft guidance “Labeling for Biosimilar and Interchangeable Biosimilar …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on September 15, 2023 - 15:22 GMT

  

  FDA Supports Innovation in Animal Biotechnology, Veterinary Products, Food for Animals Through New Comprehensive Agenda

  For Immediate Release: September 15, 2023 Today, the U.S. Food and Drug Administration announced it is taking new steps to further modernize its approach to evaluating and supporting the development of innovative animal and veterinary products, to increase …

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• Published on September 12, 2023 - 15:04 GMT

  

  FDA Issues Warning Letters to Firms Marketing Unapproved Eye Products

  FDA News Release Agency Warns Eight Companies Regarding Their Unapproved Ophthalmic Drugs For Immediate Release: September 12, 2023 The U.S. Food and Drug Administration has issued warning letters to eight companies for manufacturing or marketing …

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• Published on September 11, 2023 - 17:52 GMT

  

  FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants

  For Immediate Release: September 11, 2023 Today, the U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 30, 2023 - 20:24 GMT

  

  FDA Issues Warning Letters to Three Infant Formula Manufacturers

  For Immediate Release: August 30, 2023 Today, the U.S. Food and Drug Administration issued warning letters to three infant formula manufacturers as part of the agency’s ongoing commitment to enhance regulatory oversight to help ensure that the industry is …

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• Published on August 29, 2023 - 19:15 GMT

  

  FDA Roundup: August 29, 2023

  For Immediate Release: August 29, 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 informed consumers in Treating and Dealing with ADHD about FDA-approved treatments …

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• Published on August 25, 2023 - 20:03 GMT

  

  FDA Roundup: August 25, 2023

  For Immediate Release: August 25, 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 announced the signing of a first-of-its kind Regulatory Partnership Arrangement with …

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• Published on August 24, 2023 - 21:21 GMT

  

  FDA Approves First Biosimilar to Treat Multiple Sclerosis

  For Immediate Release: August 24, 2023 The U.S. Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS). …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 23, 2023 - 16:23 GMT

  

  FDA Names First Deputy Commissioner for Proposed, Unified Human Foods Program

  For Immediate Release: August 23, 2023 Today, the U.S. Food and Drug Administration is announcing the selection of James “Jim” Jones to serve as the first Deputy Commissioner for Human Foods. The new executive position will lead the charge in setting and …

  Distribution channels: Healthcare & Pharmaceuticals Industry
• Published on August 21, 2023 - 21:46 GMT

  

  FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants

  For Immediate Release: August 21, 2023 Today, the U.S. Food and Drug Administration approved Abrysvo (Respiratory Syncytial Virus Vaccine), the first vaccine approved for use in pregnant individuals to prevent lower respiratory tract disease (LRTD) and …

  Distribution channels: Healthcare & Pharmaceuticals Industry