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New FDA Draft Guidance Data Monitoring Committees In Clinical Trials

New FDA Draft Guidance Data Monitoring Committees In Clinical Trials
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Secure By Design And Default Compliant Medical Device Development

Secure By Design And Default Compliant Medical Device Development
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John giantsidisNational security agencyDevice design and development security testingInfrastructure security agencyCyberacta incDevice design and development security requirementsBureau of investigationFederal bureauQuality system

CyberActa Announces Appointment of Senior Executive Advisor

CyberActa Announces Appointment of Senior Executive Advisor
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United statesCommonwealth of massachusettsRobert bob antonelliJohn giantsidisBob antonelliInformation technologyVeridat cyberacta incCyberacta incFresenius medical careRobert antonelliSenior executive advisorSenior executiveVice presidentExecutive advisor

FDA s Grace Period For Medical Device Cybersecurity Is Over Are You Ready

FDA s Grace Period For Medical Device Cybersecurity Is Over Are You Ready
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John giantsidisCyberacta incDrug omnibus reform actRisk based vulnerability managementNot just patchFederal foodCosmetic act

FDA Seeks Input On AI Adoption In Drug Development And Manufacture

FDA Seeks Input On AI Adoption In Drug Development And Manufacture
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John giantsidisMaria papademetrisDevelopment of drugNonclinical researchModel developmentClinical researchDrug development discussion paperCyberacta incMedical thingsUsing artificial intelligenceMachine learningArtificial intelligenceLed governanceManufacturing practice guidanceActive pharmaceutical ingredients