FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on October 26, 2023 - 15:22 GMT

FDA Raises Concerns About Probiotic Products Sold for Use in Hospitalized Preterm Infants

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 24, 2023 - 20:17 GMT

FDA Approves New Therapy for Rare Form of Blood Cancers Called Myelodysplastic Syndromes

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 ( …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 24, 2023 - 18:52 GMT

FDA Roundup: October 24, 2023

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 20, 2023 - 19:30 GMT

FDA Roundup: October 20, 2023

For Immediate Release: October 20, 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 fiscal year (FY) 2024 fee rates and payment procedures for animal drugs …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 19, 2023 - 13:40 GMT

FDA Deputy Commissioner for Human Foods Commits to Fulfilling Vision of Proposed Program

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 17, 2023 - 19:50 GMT

FDA Roundup: October 17, 2023

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 13, 2023 - 17:22 GMT

FDA Roundup: October 13, 2023

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) …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 12, 2023 - 19:01 GMT

FDA Denies Marketing of Six Flavored Vuse Alto E-Cigarette Products Following Determination They Do Not Meet Public Health ...

FDA News Release Company Must Stop Marketing Unauthorized Products or Risk Enforcement For Immediate Release: October 12, 2023 Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) to R.J. Reynolds Vapor Company for six …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 11, 2023 - 13:53 GMT

FDA Establishes New Advisory Committee on Digital Health Technologies

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

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 …

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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