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The lowest-cost patient-centered initiatives — such as involving advisory groups and offering patient counseling and education — led to the largest returns in clinical trial performance. Read More
The development process for biosimilar heparins no longer requires a comparative clinical trial, according to new guidance from the European Medicines Agency. Read More
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bladder cancer should depend on whether patients have active disease at the time of enrollment, the FDA said, in a draft guidance that focuses on developing drugs and biologics for disease that has not responded to standard bacillus Calmette-Guerin immunotherapy.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A year after the first approval of a treatment for female sexual desire disorders, the FDA has released draft guidance for drugmakers looking to develop the next female Viagra.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