Regulatory Affairs

New FDA Guidance Outlines Trial Design for BCG-Unresponsive NMIBC Drugs

Sponsors of drugs for treatment of bacillus Calmette-Guérin (BCG)-unresponsive nonmuscle invasive bladder cancer should use complete response rates in carcinoma in situ patients as their primary endpoint, the FDA said in a final guidance that is not significantly different from the agency’s 2016 draft. Read More