
FDA Releases Guidance on Developing Treatments for Bladder Cancer
The agency published guidance to help pharma companies in the clinical development of treatments for bacillus Calmette-Guerin (BCG)-unresponsive nonmuscle invasive bladder cancer.
FDA published
The guidance, which may also apply to the development of drugs for other forms of nonmuscle invasive bladder cancer, addresses early and late-phase development and other considerations such as risk management and nonclinical safety. Statistical analysis and clinical trial design are not covered in the guidance. For those topics, FDA recommends sponsors follow International Council for Harmonization (ICH) guidelines E9 Statistical Principles for Clinical Trials and E10 Choice of Control Group and Related Issues in Clinical Trials, respectively.
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