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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: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices2024-03-10T15:39:28+00:00

USA | Draft FDA Guidance: Key Information and Facilitating Understanding in Informed Consent

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USA | Draft FDA Guidance: Key Information and Facilitating Understanding in Informed Consent2024-03-10T15:31:54+00:00

USA | New Draft FDA Guidance: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products

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USA | New Draft FDA Guidance: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products2024-02-08T13:27:50+00:00

USA | FDA Finalises RWD Guidance on Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products

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USA | FDA Finalises RWD Guidance on Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products2024-01-09T14:36:31+00:00

USA | FDA Finalises Guidance on “Data Standards for Drug and Biological Product Submissions Containing Real-World Data

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USA | FDA Finalises Guidance on “Data Standards for Drug and Biological Product Submissions Containing Real-World Data2024-01-09T14:24:58+00:00
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