FDA – BCG-unresponsive nonmuscle invasive bladder cancer: developing drug and biological products for treatment Guidance for industry (Catapult’s regulatory round-up – August 2024)
The FDA has issued a draft guidance which provides recommendations for the development of drug and biological products for the treatment of patients with bacillus Calmette-Guérin (BCG)-unresponsive nonmuscle invasive bladder cancer (NMIBC) and is intended for pharmaceutical sponsors, the academic community, and other interested parties. This guidance discusses pathological diagnosis and staging, risk stratification, and trial design, including assessment of appropriate clinical endpoints. The deadline for comments is 9 October 2024.
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 – BCG-unresponsive nonmuscle invasive bladder cancer: developing drug and biological products for treatment Guidance for industry (Catapult’s regulatory round-up – August 2024). ELSIBI. Consulté le 19 janvier 2025 à l’adresse https://doi.org/10.58079/12mjv
