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US FDA Expands Drug Development Tool Qualification Program With ISTAND Pilot

 
• By Kate Rawson

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.

Different construction tools with hand tools for home renovation on wooden board maintenance and repairing concept.

The US Food & Drug Administration is expanding the range of drug development tools (DDTs) that can formally apply for qualification by the agency via a new pilot program: Innovative Science and Technology Approaches for New Drugs (ISTAND).

Announced by the agency on 30 November, the pilot program will allow sponsors and consortia to seek formal FDA qualification for tools like clinician-reported outcomes (ClinROs) through remote study...

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