AUSTRALIA | Updated Requirements for Post-Marketing Surveillance Studies
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USA – Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices
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UK – MHRA: Software and AI as a Medical Device Change Programme
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Brazil – Government Publishes Resolution that Strengthens the Role of Research Participants
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- USA – New FDA Draft Guidance for Industry: “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products Gallery
USA – New FDA Draft Guidance for Industry: “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products
USA – New FDA Draft Guidance for Industry: “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products
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UK – MHRA Launches Public Consultation on Future of Medical Device Regulation
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Canada – Proposed Revision of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2 (2018))
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UK – The Health Research Authority Moves to Make Research Transparency the Norm
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New Zealand – New Online Research Ethics Committee Application Tool (ETHICS RM)
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