U.S. Food and Drug Administration Press Releases - EIN Presswire

Published on November 22, 2024 - 01:04 GMT

Upholding Public Trust: FDA Office of Criminal Investigations’ Crucial Role in Bringing Drug Criminals to Justice

Image By: Justin D. Green, MBA, MDiv., Assistant Commissioner, FDA Office of Criminal Investigations A few significant ways the U.S. Food and Drug Administration protects public health is through facilitating product recalls or market withdrawals and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 22, 2024 - 01:04 GMT

FDA Patient Engagement Partnerships

The Reagan-Udall Foundation for the Food and Drug Administration (the Foundation) is an independent 501(c)(3) organization created by Congress “to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 21, 2024 - 17:15 GMT

F&S Fresh Foods Recalls Whole Foods Market Organic Carrot Sticks and Organic Carrots & Celery Because of Possible Health Risk Due ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Food & Beverage Industry

Published on November 21, 2024 - 17:12 GMT

FDA grants accelerated approval to zanidatamab-hrii for previously treated unresectable or metastatic HER2-positive biliary tract ...

On November 20, 2024, the Food and Drug Administration granted accelerated approval to zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals, Inc.), a bispecific HER2-directed antibody, for previously treated, unresectable or metastatic HER2-positive (IHC 3+) …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 21, 2024 - 16:15 GMT

Drug Trials Snapshot: LUMISIGHT

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “ …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 20, 2024 - 19:02 GMT

Mxbbb Issues Voluntary Nationwide Recall of Umary Acid Hyaluronic Due to the Presence of Diclofenac and Omeprazole

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Food & Beverage Industry

Published on November 20, 2024 - 16:05 GMT

FDA approves updated drug labeling for fludarabine phosphate under Project Renewal

On November 19, 2024, the Food and Drug Administration approved updated drug labeling for fludarabine phosphate (Fludarabine Phosphate Injection, Sandoz) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 20, 2024 - 05:20 GMT

Babcock Dairy Expands Recall on Orange Custard Chocolate Chip and Chocolate Peanut Butter Due to Undeclared Egg

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Food & Beverage Industry

Published on November 20, 2024 - 01:05 GMT

BsUFA III Regulatory Science Pilot Program: Program Updates - 01/22/2025

On This Page Date: January 22, 2025 Time: 1:00 PM - 3:00 PM ET AGENDA Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT (Hosted by CDER SBIA) The U.S. Food and Drug Administration (FDA) Biosimilar User Fee Act (BsUFA) III Regulatory …

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Published on November 19, 2024 - 22:30 GMT

FDA Roundup: November 19, 2024

For Immediate Release: November 19, 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 request for information (RFI) on per- and polyfluoroalkyl substances (PFAS) …

Distribution channels: Food & Beverage Industry

Published on November 19, 2024 - 19:44 GMT

Frontier Biologics, LLC - 686059 - 11/01/2024

Delivery Method: VIA EMAIL AND UNITED PARCEL SERVICE Reference #: CBER 25-686059 Product: Biologics Drugs Recipient: Recipient Name Chad W. Justice Recipient Title President/Founder Frontier Biologics, LLC 720 Jewell Drive Waco, TX 76712 United States Chad …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 19, 2024 - 18:29 GMT

Endo Expands Voluntary Recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Due to Potential Product Carton Strength ...

Summary Company Announcement Date: November 18, 2024 FDA Publish Date: November 19, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Mislabeled with the incorrect strength on the carton Company Name: Endo, Inc. Brand Name: Brand …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 19, 2024 - 17:17 GMT

HON-E-LING may be harmful due to hidden drug ingredients

[11-19-2024] The Food and Drug Administration is advising consumers not to purchase or use HON-E-LING, a product promoted for sexual enhancement on various websites, and possibly in some retail stores. This product was identified during an examination of …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 19, 2024 - 17:17 GMT

From Our Perspective: OMUFA – Past, Current, and Future

Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research and Theresa Michele, M.D., Director, CDER Office of New Drugs’ Office of Nonprescription Drugs CDER Director, Patrizia Cavazzoni, M.D. Over-the-Counter (OTC) drugs have long …

Distribution channels: Healthcare & Pharmaceuticals Industry