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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

UK | Changes to the Confidentiality Advisory Group (CAG) Meeting Guidance and Contact Information

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UK | Changes to the Confidentiality Advisory Group (CAG) Meeting Guidance and Contact Information2023-12-04T13:48:54+00:00

NETHERLANDS | New Investigational In Vitro Diagnostic Medical Device Dossier template Available

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NETHERLANDS | New Investigational In Vitro Diagnostic Medical Device Dossier template Available2023-11-05T09:58:54+00:00

USA | Draft FDA Guidance – Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products

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USA | Draft FDA Guidance – Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products2023-09-05T11:18:16+00:00

USA | Advancing Real-World Evidence Program Submission Deadline and New FAQs 

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USA | Advancing Real-World Evidence Program Submission Deadline and New FAQs 2023-09-05T11:11:37+00:00
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