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Recentes

  • FDA Draft Guidance General Considerations for Patient Preference Studies February 2026
  • Open consultation: Medical devices regulations: targeted consultation on the indefinite recognition of CE marked devices
  • Health Technology Assessment: HTA 2025 Annual Report
  • Guidance for applicants for the preparation of the ‘precise scope’ section of the variation application form
  • New Eurachem Guide to Quality in Analytical Chemistry Released – 4th Edition (2026)
  • Harmonised ICH M15 Guideline, General Principles for Model-informed Drug Development, Adopted
  • Computer Software Assurance for Production and Quality Management System Software
  • FDA CDER – 2025 New Drug Therapy Approvals: key takeaways

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