viernes, 19 de febrero de 2010

FDA Drug Safety Communication


FDA Drug Safety Communication: New safety requirements for Long-Acting Inhaled Asthma Medications called Long-Acting Beta-Agonists (LABAs)
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm200776.htm


Orange Book FR Safety or Effectiveness Determinations List (PDF) (PDF - 134KB)
http://www.fda.gov/downloads/Drugs/InformationOnDrugs/ApprovedDrugs/ApprovedDrugProductswithTherapeuticEquivalenceEvaluationsOrangeBook/UCM119207.pdf


Questions and Answers: New Safety Requirements for Long-Acting Asthma Medications called Long-Acting Beta Agonists (LABAs)
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm200719.htm


Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) (updated)
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm082196.htm


Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between July - September 2009
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm199544.htm


Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April - June 2009
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm199543.htm


Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between January - March 2009 (updated)
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm185260.htm


Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between October - December 2008 (updated)
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm161063.htm

Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April - June 2008 (updated)
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm085916.htm


Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between January - March 2008 (updated)
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm085914.htm

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