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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 States , Drug Administration , Risk Evaluation , Mitigation Strategy , Aside Abortion Politics , Medication Guide , Assure 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 Odonnell , Kelee Petzelt , Saneel Vasram , Drug Administration , International Fast Healthcare Interoperability Resources , United Biosource , Electronic Health Records , Prnewswire United Biosource , Health Level Seven , Hooks Services , Risk Evaluation , Mitigation Strategies , Case Coordinator , Natalieo Donnell , Risk Management , Assure Safe Use , Program Director ,

Maximizing REMS Potential to Reduce Risk of Errors, Patient Harm

Incorporate Program Requirements Into Systems and Workflows. ....

Congressional Research Service , Assure Safe Use , Accessed 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 States , Zydus Lifesciences , Drug Administration , Zydus Lifesciences Limited On , Zydus Lifesciences Limited , United States Food , Isotretinoin Capsules , Risk Evaluation , Mitigation Strategy , Assure Safe Use , Lifesciences 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 States , Drug Administration , Zydus Lifesciences , Isotretinoin Capsules , Lifesciences Limited , United States Food , Risk Evaluation , Mitigation Strategy , Assure Safe Use , Zydus Lifesciences Limited ,