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Tag: Regulatory Updates
BioPharma - Regulatory

Pharma/Biotech – USA, Europe and Asia Regulatory Updates Roundup – Jan 2025

USA FDA Authorizes First-in-Class Non-Opioid Thera...
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Medical Device - Regulatory

Medical Devices – USA, Europe and Asia Regulatory Updates Roundup – Jan 2025

USA Guidance on Premarket Approval (PMA) and Human...
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Medical Device - Regulatory

New/Key MDCG guidances in 2024

The European Commission continues to refine and ex...
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BioPharma - Regulatory

Pharma/Biotech – USA, Europe and Asia Regulatory Updates Roundup – Oct 2024

USA FDA approves neoadjuvant/adjuvant nivolumab fo...
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Medical Device - Regulatory

Medical Devices – USA, Europe and Asia Regulatory Updates Roundup – Oct 2024

USA Voluntary Malfunction Summary Reporting (VMSR)...
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BioPharma - Regulatory

Pharma/Biotech – USA, Europe and Asia Regulatory Updates Roundup – Sept 2024

USA FDA Clears First-in-Class Non-Opioid Treatment...
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