STAT

FDA commissioner: ‘Smarter,’ real-time clinical trials could transform drug development

Why does it take a new drug 10 years, on average, to come to market? Part of the reason lies in the dead time in the process. Historically, trials have required tedious tabulations and repeated ...
Monthly Prescribing Reference

FDA Moves to Real-Time Clinical Trial Patient Monitoring, Faster Drug Review

This shift aims to turn the traditional, stop-and-go process of drug testing and reporting into a continuous stream of live data. HealthDay News — The US Food and Drug Administration (FDA) is moving ...
RAPS

FDA allows sponsors to spread out costs in revised IND charging guidance

The US Food and Drug Administration (FDA) on Monday issued draft guidance providing advice to sponsors about when and how they can charge for an investigational new drug in a clinical trial or under ...
Hosted on MSN

FDA moves to cut costs for biosimilar drug development

WASHINGTON, D.C. — The U.S. Food and Drug Administration announced new draft guidance aimed at reducing the cost and complexity of developing biosimilar medicines, a move the agency says could help ...
Medical Xpress

FDA moves to real-time clinical trial patient monitoring, faster drug review

The U.S. Food and Drug Administration (FDA) is moving to speed drug development and review by launching real-time clinical trials. The move could soon mean more options for patients who need ...