The Food and Drug Administration (FDA) is announcing a public Workshop on “Device Improvements for Pediatric X-ray Imaging.” The main purpose of the workshop is to discuss the draft guidance “Pediatric Information for X-ray Imaging Device Premarket Notifications.” This guidance will apply to x-ray computed tomography, general and dental radiography, and diagnostic and interventional fluoroscopy…
Draft Guidance for Industry and Food and Drug Administration Staff – Pediatric Information for X
DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document issued on: May 10, 2012 You should submit comments and suggestions regarding this draft document within 120 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets…
Comunicado de la FDA sobre la seguridad de los medicamentos: Información actualizada sobre la interacción entre el medicamento Victrelis (boceprevir) y ciertos medicamentos reforzados inhibidores de la proteasa del VIH
Esta actualización es a manera de seguimiento del Comunicado de la FDA sobre la seguridad de los medicamentos del 4 de febrero del 2012: Importante interacción entre el medicamento Victrelis (boceprevir) y los medicamentos inhibidores de la proteasa del virus de inmunodeficiencia humana (VIH) reforzados con ritonavir. Anuncio de seguridad El 26 de abril del…
FDA Drug Safety Communication: Safety review update of cancer drug Revlimid (lenalidomide) and risk of developing new types of malignancies
This update is in follow-up to the FDA Drug Safety Communication: Ongoing safety review of Revlimid (lenalidomide) and possible increased risk of developing new malignancies. Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare Professionals Data Summary  Safety Announcement [5-07-2012] The U.S. Food and Drug Administration (FDA) is informing the public of an increased risk…
Mammography Facility Adverse Event and Action Report
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Consumer Information on: Presillion plus CoCr Coronary Stent on RX System
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Summary Information for: Presillion plus CoCr Coronary Stent on RX System
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Comunicado de la FDA sobre la seguridad de los medicamentos: Nueva advertencia y contraindicación sobre medicamentos para la presión arterial que contienen aliskiren
Anuncio de seguridadInformación adicional para pacientesInformación adicional para profesionales de la saludResumen de datos Anuncio de seguridad El 20 de abril del 2012, la Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) advirtió sobre la probabilidad de riesgos por el uso de medicamentos para la presión arterial que contienen…