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

Published on December 19, 2025 - 15:27 GMT

FDA Explores New Contracting Approach to Advance Public Health Innovation

For Immediate Release: December 19, 2025 The U.S. Food and Drug Administration has issued a Request for Information (RFI) seeking input from venture capital firms on developing a new contracting approach to strengthen collaboration between the agency and …

Distribution channels: Food & Beverage Industry

Published on December 19, 2025 - 01:46 GMT

Antithrombin III (Human)

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Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 19, 2025 - 01:46 GMT

Coagulation Factor VIIa (Recombinant) - JNCW

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Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 19, 2025 - 01:46 GMT

FDA Inspections of Clinical Investigators

Issued by: Guidance Issuing Office Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice This guidance is intended to provide information about FDA inspections of clinical …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 19, 2025 - 01:46 GMT

FDA Institutional Review Board Inspections

Issued by: Guidance Issuing Office Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice This guidance is intended to provide information about FDA inspections of Institutional …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 19, 2025 - 00:40 GMT

A.S.K. Foods, LLC Issues Allergy Alert on Undeclared Soy in Publix Rice & Pigeon Peas

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 December 18, 2025 - 18:07 GMT

Boss Dairy Farms Voluntarily Recalls Retail Mild Cheddar Cheese 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 December 18, 2025 - 12:59 GMT

FDA approves amivantamab and hyaluronidase-lpuj for subcutaneous injection

On December 17, 2025, the Food and Drug Administration approved amivantamab and hyaluronidase-lpuj (Rybrevant Faspro, Janssen Biotech, Inc.) for subcutaneous injection for adult patients across all indications approved for the intravenous formulation of …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 18, 2025 - 03:18 GMT

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

Docket Number: FDA-2023-D-4395 Issued by: Guidance Issuing Office Center for Devices and Radiological Health Center for Biologics Evaluation and Research Download the Current Final Guidance Download the Revised Final Guidance FDA recognizes and anticipates …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 18, 2025 - 03:18 GMT

Procleix Babesia Assay

STN# 125673 Proper Name: Procleix Babesia Assay Tradename: Procleix Babesia Assay Manufacturer: Grifols Diagnostics Solutions Inc. Indication: The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the detection of RNA …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 18, 2025 - 03:17 GMT

BK251265 - Ortho Elution Kit

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 December 18, 2025 - 03:17 GMT

Cleared 510(k) Submissions with Supporting Documents - 2025

This list includes cleared 510(k) submissions for 2025 for which we have supporting documents available and reflects the information as of the clearance date. It is not updated with regard to applicant or application status change. The clearances are …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 18, 2025 - 00:29 GMT

FDA grants regular approval to rucaparib for metastatic castration-resistant prostate cancer

On December 17, 2025, the Food and Drug Administration (FDA) approved rucaparib (Rubraca, pharmaand GmbH) for adults with a deleterious BRCA mutation (BRCAm) (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 17, 2025 - 23:19 GMT

Primavera Nueva Inc. Issues Voluntary Recall of Select 4-Count Tamales 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 Summary Company …

Distribution channels: Food & Beverage Industry

Published on December 16, 2025 - 23:22 GMT

Heparin Importation

Historically, serious injuries and deaths have been associated with the use of contaminated heparin. FDA expects all imported heparin sodium lots to be compliant with the latest US Pharmacopeia (USP) specifications and FDA’s regulatory standards to ensure …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 16, 2025 - 22:38 GMT

Fractionated Plasma Products

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Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 16, 2025 - 19:55 GMT

Zydus Lifesciences Limited - 685224 - 12/09/2025

Reference #: FEI 3013712903 Product: Drugs Recipient: Recipient Name Dr. Sharvil Patel Recipient Title Managing Director Zydus Lifesciences Limited Zydus Corporate Park, S.G. Highway Nr. Vashnodevi Circle Ahmedabad 382482 India Issuing Office: United …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 16, 2025 - 19:55 GMT

MediNatura New Mexico, Inc. Expands Voluntary Nationwide Recall of ReBoost Nasal Spray and to include ClearLife Allergy Nasal ...

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 December 16, 2025 - 19:03 GMT

StuffbyNainax LLC Issues Voluntary Nationwide Recall of MR.7 SUPER 700000 Dietary Supplement Due to the Presence of Undeclared ...

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: Healthcare & Pharmaceuticals Industry

Published on December 16, 2025 - 17:26 GMT

Green Valley Fertility Partners - 720249 - 12/03/2025

Delivery Method: VIA UPS and Electronic Mail Reference #: CBER 26-720249 Product: Biologics Recipient: Recipient Name Jeffrey Fisch, MD Recipient Title Medical Director Green Valley Fertility Partners 2950 W. Horizon Ridge Henderson, NV 89074 United States …

Distribution channels: Healthcare & Pharmaceuticals Industry