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FDA Drug Safety Communication: Safety Review update on reports of Hepatosplenic T-Cell Lymphoma in adolescents and young adults receiving tumor necrosis factor (TNF) blockers, azathioprine and/or mercaptopurine
Safety Announcement Additional Information for Patients Additional Information for Healthcare Professionals Data SummaryTable Safety Announcement [04-14-2011] The U.S. Food and Drug Administration (FDA) is informing the public that it continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL), primarily in adolescents and young adults being…
Guidance for Industry and FDA Staff
Document issued on: April 14, 2011 For questions regarding this document contact Richard Felten at 301-796-6392 by email at [email protected]. U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological Health General Surgery Devices Branch Division of Surgical, Orthopedic and Restorative DevicesOffice of Device Evaluation Preface Public Comment Written comments and…
Guidance for Industry and FDA Staff – 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75
Document issued on: April 13, 2011 This document supersedes 30-Day Notices and 135-Day PMA Supplements for Manufacturing Method or Process Changes, issued on February 19, 1998. For questions regarding this document contact Anastacia Bilek at 301-796-5588 or at [email protected] at CDRH or the Office of Communications, Outreach and Development (CBER) at 301-827-1800 or 800-835-4709. U.S….
Clinical Investigator Status (Biologics)
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Benicar (olmesartan): Ongoing Safety Review
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Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults
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Class I Medical Device Recall: Penumbra Inc., Penumbra Coil 400
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Class I Medical Device Recall: iCAD (formerly Xoft Inc.), Axxent® FlexiShield Mini, Model F5300
Recall Class: Class I Date Recall Initiated: Feb. 3, 2011 Product: Axxent® FlexiShield Mini, Model F5300. This product was manufactured from Sept. 11, 2009 through June 28, 2010, and distributed nationwide from Oct. 2009 through Dec. 2010. Use: The Xoft Axxent Flexishield Mini device consists of a circular silicone rubber pad containing tungsten particulate. The pad is…
Axxent FlexiShield Mini by iCAD (formerly Xoft Inc.): Recall- Product May Shed Particles of Tungsten
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