AUSTRALIA | Updated Requirements for Post-Marketing Surveillance Studies
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- USA – New FDA Draft Guidance for Industry: “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological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USA – New FDA Draft Guidance for Industry: “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological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USA – New FDA Draft Guidance for Industry: “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological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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USA | New eCFR Website
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BULGARIA | New Version of the ECKI NIS SOP
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EU | HMA-EMA Big Data Steering Group 2021 – 2023 Workplan
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SPAIN | AEMPS Updates – Relevant to ICFs
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LATVIA | REC Submission Requirement Changes
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