Vetoquinol USA, Inc. Recalls Six Lots of FOLLTROPIN Injectable Kits for Cattle Due to Presence of Particulate Matter in Sterile Diluent Vial
Summary Company Announcement Date: November 26, 2025 FDA Publish Date: December 02, 2025 Product Type: Animal & Veterinary Reason for Announcement: Recall Reason Description Presence of particulate matter Company Name: Vetoquinol USA Brand Name: Product...Monoclonal Antibodies: Streamlined Nonclinical Safety Studies
Docket Number: FDA-2025-D-4634 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Monoclonal Antibodies: Streamlined...Rhyz Analytical Labs – 715298
Delivery Method: Via Electronic Mail – Return Receipt Requested Reference #: 320-26-17 Product: Drugs Recipient: Recipient Name Mr. Glen S. Putnam Recipient Title Senior Director of Global Quality Rhyz Analytical Labs 75 West Center St.Provo, UT 84601-4432United...Turbare Manufacturing – 713516 – 09/16/2025
Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Product: Drugs Recipient: Recipient Name Laura Martin Turbare Manufacturing 925 Jeanette DriveConway, AR 72032-6651United States Issuing Office: Center for Drug Evaluation and Research...Advancing Real-World Evidence in FDA Regulatory Decision Making
On This Page Date: December 11, 2025 Time: 12:00 p.m. – 1:00 p.m. ET Speaker Marie Bradley, PhDSenior Advisor for Real-World Evidence Office of Medical PolicyCenter for Drug Evaluation and Research U.S. Food and Drug AdministrationAbout the SpeakerDr. Marie...PQ Pharmacy, LLC – 715795
Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Product: Drugs Recipient: Recipient Name Hale N. Dimetry Recipient Title President PQ Pharmacy, LLC 15215 Technology DriveBrooksville, FL 34604-0690United States Issuing Office: Center...Early Alert: Glucose Monitor Sensor Issue from Abbott Diabetes Care
This communication is an FDA Early Alert. The FDA has become aware of a potentially high-risk issue. The FDA will keep the public informed and update this web page as significant new information becomes available.Affected ProductThe FDA is aware that Abbott Diabetes...QTc Info in Human Prescription Drug and Biological Product Label
Docket Number: FDA-2023-D-2439 Issued by: Guidance Issuing Office Oncology Center of Excellence Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance is intended to assist applicants with incorporating heart rate-corrected...All Drug Purchases Are
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