Class I Medical Device Recall: Fresenius Medical Care North America, CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors for Use with the Blood Volume Monitor

Recall Class: Class I Date Recall Initiated: November 11, 2010 Product: CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors for Use with the Blood Volume Monitor This recall affects ONLY Part Number 03-2695-9 and ONLY Part Number 03-2795-7. To locate the specific lot numbers, see the Firm Press Release [...]

SOPP 8406: Managing PDUFA User Fee Payments and Billing Activities

Version #4 Effective Date: Date: October 19, 2009 1. Purpose This document describes the procedures used to determine the accuracy of information submitted by an applicant and to verify user fee payments relative to the Prescription Drug User Fee Act (PDUFA) of 1992, as reauthorized by the Food and Drug Administration Amendments Act of 2007.  [...]

January 13, 2011 Approval Letter

Our STN:  BL 125259/112 GlaxoSmithKline BiologicalsAttention: Matthew Whitman2301 Renaissance BoulevardP.O. Box 61540King of Prussia, PA  19406-2772 Dear Mr. Whitman: We have approved your request to supplement your biologics license application for Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant, to include a Patient Package Insert to the full prescribing information. In addition, please submit [...]

CDRH Ombudsman Annual Report

  U.S. Department of Health and Human ServicesPublic Health ServiceFood and Drug AdministrationCenter for Devices and Radiological Health   I. CONTACTS An inquiry may be a question, a request for clarification, or an issue that does not rise to the level of a complaint or a dispute. A complaint is typically an expression of dissatisfaction, [...]

Consumer Information on: Arctic Front Cardiac CryoAblation Catheter

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Names: Arctic Front® Cardiac CryoAblation Catheter [...]

Acetaminophen Information

Acetaminophen Safety Information January 13, 2011 FDA Drug Safety Communication: Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for Severe Liver Failure  1/13/2011 Questions and Answers about Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit  1/13/2011 FDA limits acetaminophen in prescription combination [...]

Acetaminophen Prescription Products Limited to 325 mg Per Dosage Unit: Drug Safety Communication

[Posted 01/13/2011] AUDIENCE: Pharmacy, Pain Management ISSUE: FDA notified healthcare professionals that it has asked drug manufacturers to limit the strength of acetaminophen in prescription drug products, predominantly combinations of acetaminophen and opioids, to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients. This action will help to reduce [...]

FDA Drug Safety Communication: Update to ongoing safety review of Lantus (insulin glargine) and possible risk of cancer

  Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary References   Safety Announcement [1-12-2011] The U.S. Food and Drug Administration (FDA) is updating the public about its ongoing safety review of Lantus (insulin glargine) and a possible increased risk of cancer. Lantus is a long-acting modified version of human insulin (insulin analog) used [...]

Safe Use Initiative: FDA-Sponsored Stakeholder Meeting on Surgical Fire Prevention

  On October 22, 2010, the Food and Drug Administration held a workshop to discuss FDA regulated products implicated in surgical fires and challenges in eliminating fires.  The workshop was organized by the Center for Drug Evaluation and Research’s Safe Use Initiative team and the Center for Devices and Radiological Health Division of Patient Safety [...]

Town Hall Discussion With the Director of CDRH and Other Senior Center Management, March 10, 2011

Date, Time and Location Supplementary Information Transcript Registration Meeting Agenda Contact Us Date, Time and Location The meeting will be held on March 10, 2011, beginning at 8:00 a.m., at the following location: Irving Convention Center at Las Colinas 500 West Las Colinas Blvd Irving, Texas 75039 Phone: (972) 252-7476 The meeting will not be [...]