News Archive

EMA webinar on the use of platform technologies in the non-clinical and clinical domains

29th January 2026

The EMA are pleased to inform you that a webinar on the use of platform technologies in the non-clinical and clinical domains will be held on 2 March 2026 from 09:25 to 12:15 CET.

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FDA Clinical Decision Support Software – Final Guidance

29th January 2026

The FDA’s Clinical Decision Support Software guidance explains the agency’s regulatory approach for CDS tools used in healthcare.

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Veterinary Medicines Highlights - January 2026

29th January 2026

Quarterly news, activities and interviews from EMA Veterinary Medicines Division

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MHRA takes over chair of the International Access Consortium for 2026

27th January 2026

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has begun its 2026 term as Chair of the Access Consortium, strengthening global regulatory collaboration to improve patient access to new medicines.

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WHO statement on notification of withdrawal of the United States-of-withdrawal-of-the-united-states

26th January 2026

Title: WHO statement on notification of withdrawal of the United States

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EMA CVMP meeting highlights – 13–14 January 2026

21st January 2026

The European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) published key outcomes from its January 2026 meeting, including opinions on new veterinary medicines and updated guidance initiatives.

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EMA PRAC meeting highlights — 12–15 January 2026

21st January 2026

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) met in mid-January 2026 to review emerging safety data and ongoing pharmacovigilance activities.

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FDA draft guidance on Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products

21st January 2026

The U.S. Food and Drug Administration (FDA) has issued draft guidance to help sponsors apply Bayesian statistical methods more consistently in clinical trials supporting drug and biologics approvals.

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FDA issues warning letter to Darmerica, LLC for significant CGMP and labelling violations

21st January 2026

The U.S. Food and Drug Administration (FDA) on 8th December 2025 issued a warning letter to Darmerica, LLC following an inspection that identified major manufacturing and labelling deficiencies.

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ICH E22 General Considerations for Patient Preference Studies (Step 2 Draft Guideline)

21st January 2026

The International Council for Harmonisation (ICH) has released the Step 2 draft of the E22 guideline — General Considerations for Patient Preference Studies (PPS) — endorsed on 19 November 2025 and now open for public consultation.

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