Understanding Barriers to Medical Device Quality

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New Searchable Database for Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes

<!– –> <!– Page Last Updated: 10/31/2011 –> Page Last Updated: 10/31/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHTransparency/ucm206289.htm

Opportunities for Collaboration

The following is a sampling of drugs, drug classes or therapeutic areas that could benefit from stakeholder collaboration. Acetaminophen toxicity Benzocaine gels, liquids and topical sprays and the risk of methemoglobinemia Health literacy Long-acting beta agonists (LABA) Medication adherence Nonsteroidal anti-inflammatory drugs (NSAIDs) for the treatment of pain in geriatric patients Prescription opioids Safe injection practices [...]

FDA Drug Safety Communication: Updated information about the FDA-funded study on risk of blood clots in women taking birth control pills containing drospirenone

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PMA Final Decisions for September 2011

<!– –> <!– Page Last Updated: 10/26/2011 –> Page Last Updated: 10/26/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/ucm277367.htm

Information for Health Care Professionals: Anticipated Short Supply of Coral Snake Antivenom (Pfizer Inc. )

<!– –> <!– Page Last Updated: 10/26/2011 –> Page Last Updated: 10/26/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm212502.htm

Comunicado de la FDA sobre la seguridad de los medicamentos: 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   aquí.  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 [...]

Xigris [drotrecogin alfa (activated)]: Market Withdrawal

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Biologics Sentinel Initiative Projects

<!– –> <!– Page Last Updated: 10/24/2011 –> Page Last Updated: 10/24/2011 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Article source: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Post-MarketActivities/ucm196251.htm

Chantix (varenicline)

Audience: Healthcare professionals, consumers [UPDATE 10/24/2011] FDA has reviewed the results from two FDA-sponsored epidemiological studies that evaluated the risk of neuropsychiatric adverse events associated with the smoking cessation drug Chantix (varenicline). Neither study found a difference in risk of neuropsychiatric hospitalizations between Chantix and nicotine replacement therapy (NRT; e.g., NicoDerm patches). However, both studies [...]