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FDA Draft Guidance General Considerations for Patient Preference Studies February 2026
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “E22 General Considerations for Patient Preference Studies.” The draft guidance was prepared under the auspices of the International...
Open consultation: Medical devices regulations: targeted consultation on the indefinite recognition of CE marked devices
The Medicines and Healthcare products Regulatory Agency (MHRA) is inviting members of the public to provide their views on proposals for the approach to recognising CE marked medical devices in Great Britain. We welcome the views from anyone who will be impacted by...
Health Technology Assessment: HTA 2025 Annual Report
Health Technology Assessment: HTA Coordination Group publishes its 2025 Annual Report The Member State Coordination Group on Health Technology Assessment (HTACG) has published its 2025 Annual Report, providing an overview of the first year of application of the EU...
Guidance for applicants for the preparation of the ‘precise scope’ section of the variation application form
This guidance aims at supporting applicants in completing the 'Precise scope and Background for a change, and Justification for grouping, worksharing and classification for unforeseen changes (if applicable)' (hereinafter called the 'Precise scope') section of the...
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