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Clinical trial design in non-muscle invasive bladder cancer should depend on whether patients have active disease at the time of enrollment, the FDA said, in a draft guidance that focuses on developing drugs and biologics for disease that has not responded to standard bacillus Calmette-Guerin immunotherapy. Read More
Three clinical trial designs incorporating real-world evidence were proposed by a working group consisting of members the FDA and industry, who said the trials could possibly be used in future regulatory decisions. Read More
A year after the first approval of a treatment for female sexual desire disorders, the FDA has released draft guidance for drugmakers looking to develop the next female Viagra. Read More
Sponsors should conduct at least two randomized, double-blinded, controlled trials to establish efficacy and safety in trials for treating head lice infestations in children, the agency said in a final guidance. Read More
Future cancer immunotherapy trials need new standardized endpoints and evaluation criteria, regulators and scientists said at an FDA workshop. Read More