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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 November 14, 2023 - 20:41 GMT

FDA Roundup: November 14, 2023

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 …

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Published on October 31, 2023 - 22:11 GMT

FDA Roundup: October 31, 2023

For Immediate Release: October 31, 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 provided an update from our ongoing postmarket evaluation of Essure by posting …

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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 …

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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 …

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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 ( …

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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 …

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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 …

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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 …

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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 …

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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) …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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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