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  USA – New FDA Draft Guidance for Industry: Data Standards for Drug and Biological Product Submissions Containing Real-World Data

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  USA – New FDA Draft Guidance for Industry: Data Standards for Drug and Biological Product Submissions Containing Real-World Data

  2021, Members-Only, Moderate Update, October 2021, RWD to Support Reg Decisions, USA
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USA – New FDA Draft Guidance for Industry: Data Standards for Drug and Biological Product Submissions Containing Real-World Data

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USA – New FDA Draft Guidance for Industry: Data Standards for Drug and Biological Product Submissions Containing Real-World Datastuart.mccully2022-08-07T17:11:09+00:00

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  USA – New FDA Draft Guidance for Industry: Good Machine Learning Practice for Medical Device Development

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  USA – New FDA Draft Guidance for Industry: Good Machine Learning Practice for Medical Device Development

  2021, AI, Medical Devices, Members-Only, Moderate Update, October 2021, USA
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USA – New FDA Draft Guidance for Industry: Good Machine Learning Practice for Medical Device Development

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USA – New FDA Draft Guidance for Industry: Good Machine Learning Practice for Medical Device Developmentstuart.mccully2022-08-07T17:12:00+00:00

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  Norway – Consultation: Research Ethics Guide for Research on Human Remains

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  Norway – Consultation: Research Ethics Guide for Research on Human Remains

  2021, Members-Only, Moderate Update, Norway, October 2021
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Norway – Consultation: Research Ethics Guide for Research on Human Remains

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Norway – Consultation: Research Ethics Guide for Research on Human Remainsstuart.mccully2022-08-07T17:12:47+00:00

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  EU – EMA Guideline on Registry-Based Studies

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  EU – EMA Guideline on Registry-Based Studies

  2021, EU, Members-Only, Moderate Update, October 2021, RWD to Support Reg Decisions
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EU – EMA Guideline on Registry-Based Studies

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EU – EMA Guideline on Registry-Based Studiesstuart.mccully2022-08-07T17:13:38+00:00

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  UK | Revised Reporting Requirements for Non-CTIMPs

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  UK | Revised Reporting Requirements for Non-CTIMPs

  2021, At A Glance, Members-Only, Moderate Update, September 2021, UK

UK | Revised Reporting Requirements for Non-CTIMPs

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UK | Revised Reporting Requirements for Non-CTIMPsstuart.mccully2024-07-09T13:27:55+00:00

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  AUSTRALIA | Updated Requirements for Post-Marketing Surveillance Studies

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  AUSTRALIA | Updated Requirements for Post-Marketing Surveillance Studies

  2021, At A Glance, Australia, Members-Only, Moderate Update, September 2021

AUSTRALIA | Updated Requirements for Post-Marketing Surveillance Studies

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AUSTRALIA | Updated Requirements for Post-Marketing Surveillance Studiesstuart.mccully2024-07-09T13:21:37+00:00

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  USA – Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices

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  USA – Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices

  2021, AI, Medical Devices, Members-Only, Minor Update, September 2021, USA
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USA – Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices

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USA – Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devicesstuart.mccully2022-08-07T17:16:19+00:00

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  UK – MHRA: Software and AI as a Medical Device Change Programme

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  UK – MHRA: Software and AI as a Medical Device Change Programme

  2021, AI, Medical Devices, Members-Only, Minor Update, September 2021, UK
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UK – MHRA: Software and AI as a Medical Device Change Programme

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UK – MHRA: Software and AI as a Medical Device Change Programmestuart.mccully2022-08-07T17:17:15+00:00

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  Brazil – Government Publishes Resolution that Strengthens the Role of Research Participants

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  Brazil – Government Publishes Resolution that Strengthens the Role of Research Participants

  2021, Brazil, Members-Only, Minor Update, September 2021
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Brazil – Government Publishes Resolution that Strengthens the Role of Research Participants

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Brazil – Government Publishes Resolution that Strengthens the Role of Research Participantsstuart.mccully2022-08-07T17:17:52+00:00

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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

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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

  2021, Members-Only, Moderate Update, RWD to Support Reg Decisions, September 2021, USA
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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

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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 Productsstuart.mccully2022-08-07T17:18:58+00:00