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USA – Independent assessment of the NESTcc Test-Cases: RAND Interim Report Provides Insights from RWE Generation for Medical Devices

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USA – Independent assessment of the NESTcc Test-Cases: RAND Interim Report Provides Insights from RWE Generation for Medical Devices2022-08-07T16:50:26+00:00

USA – NESTcc publishes Data Quality Maturity Model Self-Assessment Tools to complement initial Data Quality Framework

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USA – NESTcc publishes Data Quality Maturity Model Self-Assessment Tools to complement initial Data Quality Framework2022-08-07T16:51:09+00:00

EU – Version 5 of the Questions and Answers Document for the EU Clinical Trials Regulation (Regulation EU/536/2014) has Been Published

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EU – Version 5 of the Questions and Answers Document for the EU Clinical Trials Regulation (Regulation EU/536/2014) has Been Published2022-08-07T16:51:50+00:00

AUSTRALIA – TGA Consultation on Whether or Not Certain International Scientific Guidelines Should be Adopted

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AUSTRALIA – TGA Consultation on Whether or Not Certain International Scientific Guidelines Should be Adopted2022-08-07T16:52:53+00:00

AUSTRALIA – TGA Consultation: Improving access to medicine adverse event data – sponsor survey

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AUSTRALIA – TGA Consultation: Improving access to medicine adverse event data – sponsor survey2022-08-07T16:53:41+00:00

USA – FDA Finalises Guidance on Principles for Selecting, Developing, Modifying, and Adapting PRO Instruments for Use in Medical Device Evaluation

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USA – FDA Finalises Guidance on Principles for Selecting, Developing, Modifying, and Adapting PRO Instruments for Use in Medical Device Evaluation2022-08-07T16:54:16+00:00

USA | Draft FDA Guidance: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

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USA | Draft FDA Guidance: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations2022-08-07T16:56:55+00:00

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 

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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 2022-08-07T16:57:47+00:00
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