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Mifepristone s Adverse Event Reporting: Cause for Concern at FDA

The FDA's handling of safety data for mifepristone highlights the need for comprehensive adverse event collection to protect women's health.

United statesDrug administrationRisk evaluationMitigation strategyAside abortion politicsMedication guideAssure safe use

UBC Successfully Implemented REMS Administration Software During HL7® FHIR® Connectathon

UBC Successfully Implemented REMS Administration Software During HL7® FHIR® Connectathon
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Natalie odonnellKelee petzeltSaneel vasramDrug administrationInternational fast healthcare interoperability resourcesUnited biosourceElectronic health recordsPrnewswire united biosourceHealth level sevenHooks servicesRisk evaluationMitigation strategiesCase coordinatorNatalieo donnellRisk managementAssure safe use

Maximizing REMS Potential to Reduce Risk of Errors, Patient Harm

Incorporate Program Requirements Into Systems and Workflows.

Congressional research serviceAssure safe useAccessed july

Zydus Receives Final Approval From The USFDA For Isotretinoin Capsules

Zydus Receives Final Approval From The USFDA For Isotretinoin Capsules
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United statesZydus lifesciencesDrug administrationZydus lifesciences limited onZydus lifesciences limitedUnited states foodIsotretinoin capsulesRisk evaluationMitigation strategyAssure safe useLifesciences limited

Zydus receives final approval from the USFDA for Isotretinoin Capsules USP, 10 mg, 20 mg 30 mg and 40 mg

Zydus receives final approval from the USFDA for Isotretinoin Capsules USP, 10 mg, 20 mg 30 mg and 40 mg
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United statesDrug administrationZydus lifesciencesIsotretinoin capsulesLifesciences limitedUnited states foodRisk evaluationMitigation strategyAssure safe useZydus lifesciences limited