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

Published on May 8, 2025 - 16:49 GMT

FDA grants accelerated approval to the combination of avutometinib and defactinib for KRAS-mutated recurrent low-grade serous ...

On May 8, 2025, the Food and Drug Administration granted accelerated approval to the combination of avutometinib and defactinib (Avmapki Fakzynja Co-pack, Verastem, Inc.) for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 8, 2025 - 16:44 GMT

Hans Kissle LLC Issues Allergy Alert on Undeclared Wheat (Allergen) in Hans Kissle Red Potato Bliss Salad

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 May 8, 2025 - 15:52 GMT

FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Aggressive Agency-Wide AI Rollout Timeline

For Immediate Release: May 08, 2025 In a historic first for the agency, FDA Commissioner Martin A. Makary, M.D., M.P.H., today announced an aggressive timeline to scale use of artificial intelligence (AI) internally across all FDA centers by June 30, 2025, …

Distribution channels: Food & Beverage Industry

Published on May 8, 2025 - 11:34 GMT

The Future of Registries in Oncology - 08/27/2025

On This Page Date: August 27 - 28, 2025 Day1: Wed, Aug 27 10:00 a.m. - 01:00 p.m. ET Day2: Thu, Aug 28 10:00 a.m. - 01:00 p.m. ET Image Background The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) will host a two-day virtual …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 8, 2025 - 09:20 GMT

Oasis Medical, Inc. - 707198 - 07/15/2025

Delivery Method: Via Email Reference #: 320-25-93 Product: Drugs Recipient: Recipient Name Mr. Norman Craig Delgado Recipient Title President and CEO Oasis Medical, Inc. 514 S. Vermont Avenue Glendora, CA 91741 United States Issuing Office: Center for Drug …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 7, 2025 - 23:46 GMT

Vaccines and Related Biological Products Advisory Committee May 22, 2025 Meeting Announcement - 05/22/2025

Advisory Committee Meeting | Virtual Scheduled On This Page Date: May 22, 2025 Time: 8:30 a.m. - 4:30 p.m. ET What is an advisory committee? Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 7, 2025 - 20:11 GMT

FDA CDER Overview: Certificates of Confidentiality - 05/07/2025

On This Page Visit CDER Small Business and Industry Assistance (SBIA) Homepage About this Event (Hosted by CDER SBIA) At the end of this two-part webinar, participants will understand the purpose of a Certificate of Confidentiality (CoC), be able to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 7, 2025 - 19:12 GMT

FDA Advises Consumers, Tattoo Artists, and Retailers to Avoid Using or Selling Certain Sacred Tattoo Ink Products Contaminated ...

Summary Company Announcement Date: May 07, 2025 FDA Publish Date: May 07, 2025 Product Type: Cosmetics Reason for Announcement: Recall Reason Description Tattoo inks that are contaminated with bacteria, including Pseudomonas aeruginosa. Company Name: U.S. …

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Published on May 7, 2025 - 18:49 GMT

Emerging Drug Safety Technology Meetings (EDSTM)

As announced in the Federal Register Notice on June 11, 2024, CDER has established a program called the Emerging Drug Safety Technology Program, which will administer Emerging Drug Safety Technology Meetings (EDSTM). The program provides applicants with an …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 6, 2025 - 22:44 GMT

New England Village Foods Issues Allergy Alert on Undeclared Almonds and Sesame in “19th Hole Snack Mix”

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 May 6, 2025 - 22:22 GMT

EnShiShiXiangNiShangMaoYouXianGongSi Issues Voluntary Nationwide Recall of ENDURANCE BOOST WITH HORNY GOAT WEED Capsules Due To ...

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 May 6, 2025 - 16:27 GMT

FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities

For Immediate Release: May 06, 2025 Today, the U.S. Food and Drug Administration announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products …

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Published on May 6, 2025 - 15:06 GMT

Nana Barseghian, M.D./Amicis Research Center - 708009 - 04/28/2025

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 25-HFD-45-04-01 Product: Drugs Recipient: Nana Barseghian, M.D./Amicis Research Center 19875 Nordhoff Street Northridge, CA 91324 United States Issuing Office: Center for Drug …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 6, 2025 - 08:26 GMT

M11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP)

Docket Number: FDA-2022-D-3054 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of Regulatory Policy Center for Biologics Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 6, 2025 - 02:02 GMT

Vietti Food Group Issues Allergy Alert on Undeclared Soy in 15-oz Yellowstone Brown Sugar Molasses Baked Beans

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 May 5, 2025 - 22:10 GMT

East Trading Inc., Issues Alert on Undeclared Sulfites in “Licorice Plum”

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 May 5, 2025 - 19:46 GMT

Primary Mitochondrial Diseases Virtual Public Workshop - 05/22/2025

On This Page Date: May 22, 2025 Time: 10:00 a.m. - 4:00 p.m. ET On May 22, the Reagan-Udall Foundation for the FDA, in collaboration with the Food and Drug Administration, will host a virtual public workshop on "Primary Mitochondrial Diseases." …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 5, 2025 - 19:46 GMT

OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2025 User Fees and Registration - 05/20/2025

On This Page Date: May 20, 2025 Time: 1:00 p.m. - 2:00 p.m. ET Visit CDER Small Business and Industry Assistance (SBIA) Homepage About this Event (Hosted by CDER SBIA) This webinar will provide an overview of the Over-the-Counter Drug User Fee Program ( …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on May 5, 2025 - 19:46 GMT

CDER Bioresearch Monitoring: Electronic Submission Requirements for New Drug and Biologic Licensing Applications - 05/06/2025

On This Page Visit CDER Small Business and Industry Assistance (SBIA) Homepage About this Event (Hosted by CDER SBIA) The Food and Drug Administration issued the final guidance for industry entitled “Standardized Format for Electronic Submission of NDA and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 30, 2025 - 13:05 GMT

Advisory Letters

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Distribution channels: Healthcare & Pharmaceuticals Industry