News Archive

FDA - Final Guideline: Q14 Analytical Procedure Development AND Q2(R2) Validation of Analytical Procedures

13th March 2024

Released March 2024

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FDA - Roundup 12th March 2024

13th March 2024

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

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MHRA - Equity in Medical Devices

13th March 2024

The MHRA welcomes the publication of Dame Margaret Whitehead’s Equity in Medical Devices: Independent Review

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MHRA - Med Tech Regulatory Reform blog

13th March 2024

March Edition

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EMA - Launch of new HMA-EMA catalogues of real-world data sources and studies

29th February 2024

EMA and the Heads of Medicines Agencies (HMA) have launched two public electronic catalogues: one for real-world data (RWD) sources and one for RWD studies.

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EMA - Meeting highlights from the CHMP 19-22 February 2024

29th February 2024

Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2024

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EMA - Meeting highlights from the CVMP 13-14 February 2024

29th February 2024

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-14 February 2024

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EMA - Multi-agency report highlights importance of reducing antibiotic use

29th February 2024

Countries that have decreased their consumption of antibiotics in both animals and humans have seen a reduction in antibiotic-resistant bacteria.

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FDA, MHRA, Health Canada Joint Symposium Videos

29th February 2024

View the streams from last week's FDA, MHRA, Health Canada Symposium

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ICH - ICH E2D(R1) draft Guideline presentation

29th February 2024

Available now on the ICH website The ICH E2D(R1) draft Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (ICSRs)” reached Step 2b of the ICH Process in February 2024 and entered the consultation period.

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