FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on November 16, 2023 - 15:48 GMT

Federal Judge Enters Consent Decrees Against Utah-Based Dietary Supplement Distributor and Manufacturer of Balance of Nature ...

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 …

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Published on November 15, 2023 - 20:40 GMT

Federal Court Enters Consent Decree Against Arizona-based Company for Distribution of Unapproved Contraceptive Drugs

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 …

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Published on October 31, 2023 - 22:11 GMT

FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases

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 …

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Published on October 27, 2023 - 20:53 GMT

FDA Roundup: October 27, 2023

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

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 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 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 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 - 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 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 …

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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 …

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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 …

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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 …

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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 …

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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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