US FDA Expands Drug Development Tool Qualification Program With ISTAND Pilot
ClinROs, artificial intelligence-based algorithms will be included in approval pathway. FDA is taking a crash course on new techniques for trial assessment thanks to COVID.
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Significant resources will likely depend on the next user fee agreement, but the launch of a Digital Health Center of Excellence will help the US FDA better prioritize ongoing work in the emerging field and help to identify needs for new talent, Deputy Commissioner Abernethy says.
FDA's proposed review timeline to qualify biomarkers, clinical outcome assessments, and animal models can actually be pretty quick – assuming submissions clear the initial "reviewability" hurdle.
Transparency On COVID Vaccine Clinical Holds Needed, Sharfstein Says; US FDA Advisory Cmtes Offer Venue
Former acting Commissioner Josh Sharfstein argues that while agency officials have done a commendable job in overall communication on COVID vaccine development, more information is needed on the clinical holds.