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FDA Guidance for Drug Development

The FDA has released a revised draft guidance (June 2026) on Master Protocols for Drug and Biological Product Development, reinforcing the growing role of innovative clinical trial designs in accelerating drug development.

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  • FDA Guidance for Drug Development
  • Study supporting the monitoring of the availability of medical devices on the EU market. 2 July 2026
  • IMDRF Technical Framework for Artificial Intelligence Life Cycle Management” (IMDRF AIML WG N93 – April 2026)
  • GMP CANÁBIS 2026 : “Formação conduzida com profundo domínio teórico e prático “
  • MHRA Open consultation Draft rare disease therapies regulatory framework
  • EU Delegated Acts on Well-Established Technologies (WET) under the MDR
  • CLINICAL TRIALS: EMA CTIS Sponsor Handbook
  • Update to EU GMP Guidelines – Revised Annex 19 on Reference and Retention Samples

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