New Zealand | Ethics Review Manager (ETHICS RM) Update
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Hungary | ETT Code of Bioethics Updated
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China | CMD Publishes 2022 China NMPA (CFDA) Blue Book: Revised Medical Device and IVD Regulation
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- USA – FDA Finalises Guidance on Principles for Selecting, Developing, Modifying, and Adapting PRO Instruments for Use in Medical Device Evaluation Gallery
USA – FDA Finalises Guidance on Principles for Selecting, Developing, Modifying, and Adapting PRO Instruments for Use in Medical Device Evaluation
USA – FDA Finalises Guidance on Principles for Selecting, Developing, Modifying, and Adapting PRO Instruments for Use in Medical Device Evaluation
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UK – MHRA Consultation on Proposals for Legislative Changes for Clinical Trials
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USA | Draft FDA Guidance: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
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- USA | Draft FDA Guidance: Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products Gallery
USA | Draft FDA Guidance: Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological ProductsÂ
USA | Draft FDA Guidance: Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological ProductsÂ
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HUNGARY | Updated ETT-TUKEB Medical Device Procedures
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CROATIA | Updated CEC Submission Requirements
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