fda-guidances

FDA looking to beef up its remote assessments with artificial intelligence

According to a new FDA contract notice, the agency is interested in procuring a new artificial intelligence-based Optical Character Recognition system to extract data from PDFs obtained during remote regulatory assessments. While the notice contains relatively few details, it appears that the agency is currently looking into leveraging it to benefit a biologics-specific system.

A new contract notice seeks software support to leverage AI-based data extraction technology.

Quick background: Optical Character Recognition (OCR) technology systems convert physical, printed, or scanned documents into machine-readable text, as defined by IBM. OCR software can also harness artificial intelligence (AI) to implement more advanced recognition methods.

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