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Published on September 16, 2024 - 13:40 GMT

FDA Issues Draft Guidance on Conducting Multiregional Clinical Trials in Oncology

For Immediate Release: September 16, 2024 Today, the U.S. Food and Drug Administration issued a draft guidance for industry that, when finalized, will provide sponsors with recommendations for conducting multiregional clinical trials (MRCT) in support of …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 13, 2024 - 19:39 GMT

FDA Roundup: September 13, 2024

For Immediate Release: September 13, 2024 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 published the FDA Voices: “Join FDA for the First National Hispanic/Latino …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 12, 2024 - 15:18 GMT

FDA Authorizes First Over-the-Counter Hearing Aid Software

For Immediate Release: September 12, 2024 Today, the U.S. Food and Drug Administration authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with compatible versions of the Apple AirPods Pro …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 11, 2024 - 18:10 GMT

FDA Issues Warning Letters to Two Chinese Firms Regarding Data Quality and Integrity Concerns, Violative Lab Practices

FDA News Release Firms Provided Third-Party, Nonclinical Premarket Testing; Agency Review Ongoing For Immediate Release: September 11, 2024 Today, the U.S. Food and Drug Administration issued warning letters to two Chinese nonclinical testing laboratories, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 10, 2024 - 19:49 GMT

FDA Roundup: September 10, 2024

For Immediate Release: September 10, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA posted a warning letter issued to Root Bioscience Brands LLC, doing business as …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 30, 2024 - 20:45 GMT

FDA Roundup: August 30, 2024

For Immediate Release: August 30, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Related Information ### Boilerplate The FDA, an agency within the U.S. Department of Health and Human …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 30, 2024 - 18:40 GMT

FDA Authorizes Updated Novavax COVID-19 Vaccine to Better Protect Against Currently Circulating Variants

For Immediate Release: August 30, 2024 Today, the U.S. Food and Drug Administration granted emergency use authorization (EUA) for an updated version of the Novavax COVID-19 vaccine that more closely targets currently circulating variants to provide better …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 29, 2024 - 14:47 GMT

FDA Issues Final Rule Increasing the Minimum Age for Certain Restrictions on Tobacco Sales

FDA News Release Tobacco Retailers Will Need to Verify Age for Anyone Under 30; Vending Machine Sales Will Be Restricted to 21+ Facilities For Immediate Release: August 29, 2024 Today, the U.S. Food and Drug Administration announced a final rule that …

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Published on August 27, 2024 - 19:19 GMT

FDA Roundup: August 27, 2024

For Immediate Release: August 27, 2024 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 revised the Emergency Use Authorization for Pemgarda (pemivibart) to limit its use to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 26, 2024 - 21:30 GMT

FDA Clears First Device to Enable Automated Insulin Dosing for Individuals with Type 2 Diabetes

FDA News Release Agency Supports Broader Access to Innovative Technology in Diabetes Management For Immediate Release: August 26, 2024 Today, the U.S. Food and Drug Administration expanded the indications of the Insulet SmartAdjust technology, an …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 23, 2024 - 18:49 GMT

FDA Roundup: August 23, 2024

For Immediate Release: August 23, 2024 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 a Small Entity Compliance Guide (SECG) to assist small entities, including …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 22, 2024 - 17:32 GMT

FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants

For Immediate Release: August 22, 2024 Today, the U.S. Food and Drug Administration approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent (single) component that corresponds to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 20, 2024 - 18:13 GMT

FDA Roundup: August 20, 2024

For Immediate Release: August 20, 2024 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 approved Lazcluze (lazertinib) in combination with amivantamab for the first-line …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 16, 2024 - 19:18 GMT

FDA Roundup: August 16, 2024

For Immediate Release: August 16, 2024 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 notice of a Warning Letter sent to AUSTROFOOD S.A.S. (Austrofood), the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 16, 2024 - 14:51 GMT

FDA Marketing Authorization Enables Increased Access to First Step of Syphilis Diagnosis

For Immediate Release: August 16, 2024 Today, the U.S. Food and Drug Administration granted marketing authorization to NOWDiagnostics for the First To Know Syphilis Test. This is the first at-home, over-the-counter test to detect Treponema pallidum ( …

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Published on August 15, 2024 - 18:52 GMT

FDA Issues Warning Letter to Austrofood and Continues Robust Activities to Ensure Safety of Cinnamon Products Sold in U.S.

For Immediate Release: August 15, 2024 Statement From: Jim Jones Deputy Commissioner for Human Foods - Food and Drug Administration Last fall, the U.S. Food and Drug Administration and our regulatory health partners at the North Carolina Department of …

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Published on August 15, 2024 - 13:24 GMT

FDA Announces Milestone in Sodium Reduction Efforts, Issues Draft Guidance with Lower Target Levels for Certain Foods

For Immediate Release: August 15, 2024 Image Today, the U.S. Food and Drug Administration marked a milestone building on Phase I of its voluntary sodium reduction targets and issued draft guidance for Phase II in a data-driven, stepwise approach to help …

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Published on August 13, 2024 - 21:39 GMT

FDA Roundup: August 13, 2024

For Immediate Release: August 13, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA posted two warning letters issued to BullyKamp Products LLC and Top Dog Pet Store LLC …

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Published on August 11, 2024 - 15:05 GMT

FDA Roundup: November 8, 2024

For Immediate Release: November 08, 2024 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 a final rule, to amend the color additive regulations to increase the fees for …

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Published on August 10, 2024 - 16:40 GMT

Federal Court Enters Consent Decree Against Rizo Lopez Foods Inc. Following Multistate Outbreak of Listeriosis Linked to Queso ...

For Immediate Release: October 08, 2024 Today, the U.S. District Court for the Eastern District of California entered a consent decree of permanent injunction against Rizo Lopez Foods Inc. (“Rizo Lopez Foods”), a California-based food manufacturer, and the …

Distribution channels: Healthcare & Pharmaceuticals Industry