Ressources numériques en sciences humaines et sociales OpenEdition Nos plateformes OpenEdition Books OpenEdition Journals Hypothèses Calenda Bibliothèques OpenEdition Freemium Suivez-nous

FDA outlines risk-based approach to monitoring clinical trials (Catapult’s regulatory round-up – April)

The Food and Drug Administration (FDA) has issued a final guidance to assist drug and medical device makers in developing risk-based monitoring strategies for clinical investigations involving drugs, biologics and medical devices. This guidance provides recommendations on planning a monitoring approach, developing the content of a monitoring plan, and addressing and communicating monitoring results.

Published on the 2nd of May 2023 in Catapult’s April regulatory round-up.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (19 février 2024). FDA outlines risk-based approach to monitoring clinical trials (Catapult’s regulatory round-up – April). ELSIBI. Consulté le 18 février 2026 à l’adresse https://doi.org/10.58079/vv53


Vous aimerez aussi...

Laisser un commentaire

Votre adresse e-mail ne sera pas publiée. Les champs obligatoires sont indiqués avec *

This site uses Akismet to reduce spam. Learn how your comment data is processed.