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FDA Drug Safety Communication:Use of long-term, high-dose Diflucan (fluconazole) during pregnancy may be associated with birth defects in infants
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Comunicado de seguridad de medicamentos de la FDA: Continúa la revisión de seguridad de los medicamentos por vía oral para la osteoporosis (bifosfonatos) en relación con un probable mayor riesgo de cáncer de esófago
Anuncio de seguridadInformación adicional para pacientesInformación adicional para profesionales de la saludResumen de Datos  Anuncio de seguridad El 21 de julio de 2011, la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) continúa con la revisión de los datos de estudios publicados para evaluar si el uso de los bifosfonatos por vÃa oral…
Comunicado de seguridad de medicamentos de la FDA: Continúa la revisión de seguridad de los medicamentos por vía oral para la osteoporosis (bifosfonatos) en relación con un probable mayor riesgo de cáncer de esófago
Anuncio de seguridadInformación adicional para pacientesInformación adicional para profesionales de la saludResumen de Datos  Anuncio de seguridad El 21 de julio de 2011, la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) continúa con la revisión de los datos de estudios publicados para evaluar si el uso de los bifosfonatos por vÃa oral…
Minutes From Negotiation Meeting on MDUFA III Reauthorization: July 15, 2011
FDA – Industry MDUFA III Reauthorization Meeting July 15, 2011, 10:20 – 2:10 pm FDA White Oak Building 1, Silver Spring, MD Room 4101-4105 Purpose To discuss MDUFA III reauthorization. Participants Meeting Start Time: 10:20 am To provide context for FDA’s proposed approach to mitigate program uncertainties and advance negotiations, FDA started by summarizing the…
Consumer Information on: VITROS® Immunodiagnostic Products Anti-HBe Reagent Pack, Calibrator and Controls
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 Name: VITROS® Immunodiagnostic Products Anti-HBe Reagent…
Summary Information for: VITROS Immunodiagnostic Products Anti-HBe Reagent Pack, VITROS Immunodiagnostic Products Anti-HBe Calibrator, and VITROS Immunodiagnostic Products Anti-HBe Controls
Issued July 20, 2011 Approval Order Summary Labeling Other Consumer Information This document is in a Portable Document Format (PDF). Acrobat Reader is required to read this document. Updated August 1, 2011
Summary Information for: RX Herculink Elite Renal Stent System
Issued July 20, 2011 Approval Order Summary Labeling Other Consumer Information This document is in a Portable Document Format (PDF). Acrobat Reader is required to read this document. Updated August 1, 2011
Consumer Information on: RX Herculink Elite Renal Stent System
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Class I Medical Device Recall: GEM Premier 4000 PAK Cartridges for Use on the GEM Premier 4000 System
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