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The FDA has issued a draft guidance which provides recommendations for the development of drug and biological products for the treatment of patients with bacillus Calmette-Guérin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...