MDCG 2024-5 – Guidance on the Investigator’s Brochure content – April 2024
This guidance document is intended to support sponsors in developing their Investigator’s Brochure (IB) by describing in greater detail what type of information is expected in the respective IB sections, in order to preempt questions from the competent authorities during the assessment of the clinical investigation application.
Read the news announcement published by EC Directorate-General for Health and Food Safety on 17 April 2024.
OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (21 mai 2024). MDCG 2024-5 – Guidance on the Investigator’s Brochure content – April 2024. ELSIBI. Consulté le 16 janvier 2025 à l’adresse https://doi.org/10.58079/11p02
