USA | Draft FDA Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
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USA | Draft FDA Guidance: Key Information and Facilitating Understanding in Informed Consent
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EU | Implementation Act #1 of the Health Technology Assessment Regulation Published
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BRAZIL | Use of Healthcare Databases for the Purpose of Scientific ResearchÂ
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USA | FDA Finalises Rare Diseases Considerations Guidance
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UK | 4 New Medical Device Statutory Instruments to be Implemented in 2024
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NORWAY | Norwegian Medicines Agency Becomes the Norwegian Medical Products Agency
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DENMARK | Participation in Multiple Clinical Trials
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USA | FDA Finalises Digital Health Technologies (DHT) Guidance
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