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 …
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 …
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 …
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 …
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 …
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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 …
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) …
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 …
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 …
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.
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 …
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 …
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 …
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 …
Delivery Method: Via UPS and EMAIL Reference #: CBER 25-710860 Product: Biologics Recipient: Recipient Name Glen G. Gong, PhD Recipient Title Chief Executive Officer Microvascular Tissue, Inc. 6199 Cornerstone Court East, Suite 109 San Diego, CA 92121 …
Delivery Method: Via Email Reference #: 320-26-25 Product: Drugs Recipient: Recipient Name Mr. Ross Sklar Recipient Title Chief Executive Officer Sklar Personal Care Inc. 3137 East 26th Street Vernon, CA 90058 United States Ross@starcobrands.com Issuing …
Delivery Method: VIA UPS Reference #: 320-26-23 Product: Drugs Recipient: Recipient Name Marc S. Berridge, Ph.D. Recipient Title President 3D Imaging Drug Design and Development LLC 9015 Carti Way Little Rock, AR 72205 United States Issuing Office: Center …
WARNING LETTER December 12, 2025 RE: 719339 Musclepower Enterprise Ltd. dba MONSTER KING and GE LABS: This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at the Internet addresses https://www.monsterking.eu/ …
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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