News Archive

MHRA - Patient Involvement Strategy: an assessment of progress

14th January 2025

The Medicines and Healthcare products Regulatory Agency (MHRA) published its first Patient Involvement Strategy in October 2021, covering the period to 2025.

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MHRA - Real-World Evidence Scientific Dialogue Programme

14th January 2025

A programme to help facilitate robust decision-making across the entire lifecycle of products, benefitting both regulatory and Health Technology Assessment (HTA) evaluations relevant to the UK.

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FDA - Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products

8th January 2025

Open for Consultation

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PIC/S - Two guidance documents for inspectors on remote assessments

8th January 2025

"Guidance on Remote Assessments" (PI 056-1) and "Aide Memoire on Remote Assessments" (PI 057-1). These documents have been prepared by the PIC/S Working Group on Remote Assessment.

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