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Latest From Kate Rawson
US FDA’s first guidance on patient data collection methods will be ready by June, and agency wants to get the tone right from the start; agency assures stakeholders it will be “flexible” on accepting new tools.
US FDA not looking to reduce attendance at third-party patient meetings, which deliver 'bang for the buck.' Excessive sweating is first externally led PFDD meeting for a more common condition.
Republican tax reform proposal would eliminate research credit; NORD already had its hands full countering 'misinformation' about impact of orphan drugs on drug spend; critics on Capitol Hill argue sponsors are gaming the system.
US FDA's accelerated approval pathway is more reliable and has better validated biomarkers than a decade ago, commissioner says, arguing coverage limits on AA products are not in the interest of public health.
US FDA's final patient-focused drug development meeting shows high interest clinical trial enrollment.