FDA – Optimising the dosage of human prescription drugs and biological products for the treatment of oncologic diseases guidance for industry (Catapult’s regulatory round-up – August 2024)
This guidance released in August 2024 is intended to assist sponsors in identifying an optimised dosage(s) for human prescription drugs or biological products for the treatment of oncologic diseases during clinical development and prior to submitting an application for approval of a new indication and usage. It should be considered along with the International Conference on Harmonisation (ICH) E4 guidance on Dose-Response Information to Support Drug Registration (November 1994) when identifying an optimized dosage(s).
Published on the 30th of August 2024 in Catapult’s regulatory round-up for August 2024.
OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (5 novembre 2024). FDA – Optimising the dosage of human prescription drugs and biological products for the treatment of oncologic diseases guidance for industry (Catapult’s regulatory round-up – August 2024). ELSIBI. Consulté le 16 janvier 2025 à l’adresse https://doi.org/10.58079/12mju
