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Draft Guidance for Industry and Food and Drug Administration Staff
DRAFT GUIDANCEThis guidance document is being distributed for comment purposes only. Document issued on: August 16, 2011 You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 Management (HFA-305),…
515 Program Initiative Project Status Update: Female condom, Pacemaker repair or replacement material, Ventricular bypass (assist) device
<!– –> <!– Page Last Updated: 08/16/2011 –> Page Last Updated: 08/16/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff
This guidance document is being distributed for comment purposes only. Document issued on: August 15, 2011 You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 Management (HFA-305),…
Draft Guidance for Industry and Food and Drug Administration Staff – Factors to Consider when Making Benefit
This guidance document is being distributed for comment purposes only. Document issued on: August 15, 2011 You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 Management (HFA-305),…
CDRH Learn: Medical Devices in the Home Presentations
Listed below are the courses CDRH currently offers. Additional online courses are being developed and will be posted upon completion. Course List Overview of Regulatory Requirements: Medical Devices Premarket Notification Process – 510(k) Investigational Device Exemption Process – IDE [New! 7/6/2011] Bioresearch Monitoring (BIMO) Device Establishment Registration and Listing CDRH Regulated Software: An Introduction Quality…
FDA Drug Safety Communication: Serious CNS reactions possible when linezolid (Zyvox) is given to patients taking certain psychiatric medications
 Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary References  here.  Although the exact mechanism of this drug interaction is unknown, linezolid inhibits the action of monoamine oxidase A—an enzyme responsible for breaking down serotonin in the brain. It is believed that when linezolid is given to patients taking serotonergic psychiatric medications,…
Comunicado de Seguridad de Medicamentos de la FDA: Reacciones graves en el sistema nervioso central (SNC) cuando se administra linezolid (Zyvox) a pacientes que toman ciertos medicamentos psiquiátricos
 Anuncio de seguridadInformación adicional para pacientesInformación adicional para profesionales de la saludResumen de Datos  aquÃ. Aunque se desconoce el mecanismo exacto de su interacción, el linezolid inhibe la acción de la monoamino oxidasa A, que es una enzima encargada de descomponer la serotonina en el cerebro. Se cree que cuando se administra linezolid…
Comunicado de Seguridad de Medicamentos de la FDA: Posibles reacciones graves en el SNC cuando se administra azul de metileno a pacientes que toman ciertos medicamentos psiquiátricos.
Anuncio de seguridadInformación adicional para pacientesInformación adicional para profesionales de la saludResumen de Datos  aquÃ. Aunque se desconoce el mecanismo exacto de su interacción, el azul de metileno inhibe la acción de la monoamino oxidasa A, que es una enzima encargada de descomponer la serotonina en el cerebro. Se cree que se pueden formar…