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Category: Biopharma

Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – May 2024

USA EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology In response to President Biden’s Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable,...

BioPharma, BioTech, BiotechNews, Biotechnology, DrugApproval, EMA, FDA, GlobalHealth, Healthcare, HealthcareInnovation, HealthNews, MedicalUpdates, Pharma2024, Pharmaceuticals, PharmaIndustry, PharmaNews, PharmaRegulations, PharmaTrends, RegulatoryUpdates

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Adopting a Life Cycle Approach to Software Medical Devices: Regulatory Guidelines by Singapore HSA

In March 2024, The document “Regulatory Guidance for Software Medical Devices – A Lifecycle Approach” whose third revision was issued by the Singapore Health Sciences Authority. The document is intended...

Cybersecurity, Health Tech, Healthcare Policy, Healthcare Technology, Medical Device Standards, Post Market Surveillance, Product Registration, Quality Management System (QMS), Regulatory Compliance, Singapore Healthcare, Software Regulations

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