News Archive

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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FDA - Warning Letter to Italian Company

5th September 2024

The warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. 3. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).

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MHRA - Advertising Investigations

5th September 2024

Decisions made by the MHRA following investigations into complaints about advertising for licensed medicines.

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MHRA - Appointments of four MHRA Non-Executive Directors extended until 31 August 2025

5th September 2024

Extended from 1 September 2024 until 31 August 2025.

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MHRA - Consultation on Statutory Fees

5th September 2024

Proposals on ongoing cost recovery

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