News Archive

MHRA - Drug Safety Update Newsletter

27th September 2024

September 2024

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World Health Organization - 2024 Guidance for Best Practices in Clinical Trials

26th September 2024

The World Health Organisation (WHO) has developed some guidance on best practices for clinical trials was developed following extensive global input, including public consultations.

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MHRA - An update on our plans for Med Tech regulatory change

25th September 2024

New Blog Post

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MHRA - AI Airlock pilot call for applications

24th September 2024

Apply now to join the AI Airlock pilot by the MHRA. Benefit from industry and regulatory expert collaboration, bespoke testing plans, and improved regulatory understanding.

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MHRA - Wholesalers and manufacturers guidance following agreement of the Windsor Framework

13th September 2024

Actions QPs, RPis and RPs need to take following agreement of the Windsor Framework

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EMA - Human Medicines Newsletter

5th September 2024

August 2024

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FDA - Bioresearch Monitoring Technical Conformance Guide

5th September 2024

Final guidance available

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FDA - New Final Guidances Issued by Center for Veterinary Medicine

5th September 2024

CVM GFI #63 (VICH GL1) and CVM GFI #64 (VICH GL2)

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FDA - Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products

5th September 2024

Final Guidance Released

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FDA - Roundup, 30th August 2024

5th September 2024

An at-a-glance summary of news from around the agency

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