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

Published on September 10, 2024 - 11:26 GMT

La FDA advierte a los consumidores de que no compren ni utilicen productos Umary y Amazy, ya que pueden ser perjudiciales para su ...

English Version [09/05/2024] La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) advierte a los consumidores de que no compren ni utilicen los productos Umary y Amazy, comercializados como suplementos …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 10, 2024 - 10:30 GMT

Bioterrorism and Drug Preparedness

To help prepare our country for possible bioterrorism attacks, FDA is working with other federal agencies to make sure adequate supplies of medicine and vaccines are available to the American public. This page provides links to the most current information …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 10, 2024 - 10:29 GMT

Radiation Emergencies

Leukine (sargramostim (solution) injection and sargramostim (lyophilized powder) for injection) Neulasta (pegfilgrastim) injection Neupogen (filgrastim) injection Nypozi (filgrastim-txid; FDA approved 6/26/2024) Pentetate calcium trisodium (Calcium-DTPA) …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 9, 2024 - 21:08 GMT

BsUFA II: Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act

Over the years, FDA has worked to increase communication between Agency staff and applicants during the review of novel drug and original biologic applications. The goal has been to enhance the transparency, predictability, effectiveness, and efficiency of …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 31, 2024 - 00:40 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: Food & Beverage Industry

Published on August 31, 2024 - 00:40 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 - 19:59 GMT

Tan-Alize Kozmetick ve Temizlik Urunleri Sanayi ve Ticaret A.S. - 659854 - 08/14/2024

Recipient: Recipient Name Mr. Hakan Tuna Recipient Title President/Chairman of the Board Tan-Alize Kozmetick ve Temizlik Urunleri Sanayi ve Ticaret A.S. No. 32 Omerli Mahallesi, Uran Caddesi 34799 Cekmekoy/İstanbul Turkey Issuing Office: Center for Drug …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 30, 2024 - 19:59 GMT

GDUFA Implementation: Bi-Annual Industry Regulatory Science Work Group Meeting

FDA and representatives of the generic drug industry meet bi-annually to discuss current and emerging regulatory science challenges and concerns. Minutes from these meetings are posted on this page. FDA - Industry Regulatory Science Work Group Meeting FY …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 30, 2024 - 17:33 GMT

December 4, 2024: Meeting of the Pharmacy Compounding Advisory Committee - 12/04/2024

On This Page Date: December 4, 2024 Time: 8:00 AM - 5:00 PM ET Location: Event Location FDA Headquarters FDA headquarters in White Oak, MD 10903 New Hampshire Ave Silver Spring, MD 20903 United States What is an advisory committee? Advisory committees …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 30, 2024 - 17:33 GMT

October 29, 2024: Meeting of the Pharmacy Compounding Advisory Committee - 10/29/2024

On This Page Date: October 29, 2024 Time: 8:00 AM - 5:00 PM ET Location: Event Location FDA Headquarters FDA headquarters in White Oak, MD 10903 New Hampshire Ave Silver Spring, MD 20903 United States What is an advisory committee? Advisory committees …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 30, 2024 - 17:33 GMT

2024 Meeting Materials, Pharmacy Compounding Advisory Committee

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 30, 2024 - 17:33 GMT

Eco Lips, Inc. - 631629 - 08/22/2024

Delivery Method: UPS Next Day Air Product: Drugs Recipient: Recipient Name Robert P. Shriver Recipient Title Chief Operating Officer Eco Lips, Inc. 6000 Huntington Ct NT Cedar Rapids, IA 52402 United States Issuing Office: Division of Pharmaceutical …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 30, 2024 - 16:41 GMT

Asli Fine Foods . Recalls Asli Cinnamon Powder 7 oz Because of Possible Health Risk

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 August 30, 2024 - 14:05 GMT

Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug ...

On This Page Date: October 7 - 8, 2024 Day1: Mon, Oct 7 8:30 AM - 5:35 PM ET Day2: Tue, Oct 8 8:30 AM - 5:10 PM ET Format: Hybrid (virtual via Zoom and in person) Location: The Universities at Shady Grove; Building II, 9630 Gudelsky Drive, Rockville, MD …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 30, 2024 - 12:26 GMT

Medical products for rare diseases and conditions

Rare diseases affect patients and their families. Over 7,000 rare diseases affect more than 30 million people in the United States. Many rare conditions are life threatening and most do not have treatments. The FDA works to enhance to the availability of …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 29, 2024 - 22:52 GMT

M&P Food Production Issues Allergy Alert on Undeclared Wheat and Milk in Vareniki, Pirozhki, and Blintzes

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 …

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Published on August 29, 2024 - 16:55 GMT

Spotlight on CDER science: Prescriber Perceptions of Boxed Warnings: A Qualitative study

Background An important part of CDER’s work is communicating the most up-to-date safety information for medicines to help ensure that health care providers (HCPs) and their patients can make the most informed treatment decisions. One way that CDER does …

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 28, 2024 - 19:08 GMT

April - June 2019 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System ...

Bactrim DS (sulfamethoxazole and trimethoprim) Septra (sulfamethoxazole and trimethoprim) Generic products containing sulfamethoxazole and trimethoprim Sulfatrim (sulfamethoxazole and trimethoprim)* Hypersensitivity/Acute respiratory failure The “Warnings …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 28, 2024 - 19:08 GMT

Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices

Color Additives Approved for Use in Medical Devices Part 73, Subpart D: Color additives exempt from batch certification 21 CFR Section Straight Color Year(2)Approved Uses and Restrictions §73.1015 Chromium-cobalt-aluminum oxide 1974 Linear polyethylene …

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