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USA | Reagan-Udall Report Calls for Greater Regulatory Agility and New Evidence Approaches in Rare Disease Development

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USA | Reagan-Udall Report Calls for Greater Regulatory Agility and New Evidence Approaches in Rare Disease Development2026-04-12T13:04:44+00:00

CANADA | CDA Draft Guidance Expands Economic Evaluations to Include Caregiver and Productivity Impacts

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CANADA | CDA Draft Guidance Expands Economic Evaluations to Include Caregiver and Productivity Impacts2026-04-12T12:44:14+00:00

BRAZIL | Ministry of Health Continues Implementation of Law 14,874/2024 Through Governance Appointments and Platform Oversight Measures

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BRAZIL | Ministry of Health Continues Implementation of Law 14,874/2024 Through Governance Appointments and Platform Oversight Measures2026-04-12T12:39:50+00:00

USA | FDA Publishes ICH M14 Guidance on Non-Interventional Studies Using Real-World Data & Withdraws 2013 Guidance

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USA | FDA Publishes ICH M14 Guidance on Non-Interventional Studies Using Real-World Data & Withdraws 2013 Guidance2026-04-12T12:35:30+00:00

EU | EMA Publishes Data Quality Framework for Real-World Data — Consultation Outcomes Highlight Need for Clarity and Operational Guidance

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EU | EMA Publishes Data Quality Framework for Real-World Data — Consultation Outcomes Highlight Need for Clarity and Operational Guidance2026-04-12T12:29:12+00:00

EU | ICH M14 Becomes Legally Effective — Strengthening Methodological Expectations for RWD-Based Safety Studies

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EU | ICH M14 Becomes Legally Effective — Strengthening Methodological Expectations for RWD-Based Safety Studies2026-04-12T12:28:08+00:00

EU | EU Pharma Package Moves Toward Formal Adoption — Major Reform of Pharmaceutical Legislation

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EU | EU Pharma Package Moves Toward Formal Adoption — Major Reform of Pharmaceutical Legislation2026-04-12T12:28:43+00:00
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