FDA Press Releases - EIN Presswire - Press Release Distribution Service

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FDA Draft Guidance Could Result in Safer Food Options for People with Allergies to Sesame, Other Food Allergens

FDA News Release Draft Guidance Provides Examples of Ways Manufacturers Can Significantly Minimize or Prevent Allergen Cross-Contact and Undeclared Allergens For Immediate Release: September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 …

Distribution channels:

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 …

Distribution channels:

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 September 11, 2023 - 16:59 GMT

FDA Approves First Vaccine to Prevent Disease Caused by Chikungunya Virus

For Immediate Release: November 09, 2023 Today, the U.S. Food and Drug Administration approved Ixchiq, the first chikungunya vaccine. Ixchiq is approved for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 11, 2023 - 14:28 GMT

FDA Approves First Treatment for Patients with Rare Inherited Blood Clotting Disorder

For Immediate Release: November 09, 2023 Today, the U.S. Food and Drug Administration approved Adzynma, the first recombinant (genetically engineered) protein product indicated for prophylactic (preventive) or on demand enzyme replacement therapy (ERT) in …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 11, 2023 - 14:06 GMT

FDA Clears First COVID-19 Home Antigen Test

For Immediate Release: November 09, 2023 Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) antigen test for COVID-19. ACON Laboratories’ Flowflex COVID-19 Antigen Home Test, originally authorized for …

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 …

Distribution channels:

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 …

Distribution channels:

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 …

Distribution channels:

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