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.
Peter Marks predicts that staffing challenges within CBER can be alleviated by offering employees the flexibility to work remotely – permanently. With important posts in the vaccines office still to be hired, it could be an important incentive.