FDA Eyes Commercial AI, Analytics Platforms for Drug Evaluation Process

The Food and Drug Administration is looking to deploy artificial intelligence-based capabilities to support the drug product assessments and business operations.

FDA said in a request for information notice posted Tuesday it seeks a potential contractor with expertise in pattern recognition, operations research, statistical process control and other emerging concepts to simplify regulatory oversight functions within the CDER Office of Business Informatics.

Interested parties must have the capacity to provide analyses and modeling services as well as technical assistance to the FDA for the piloting and implementation phases, according to the RFI.

The department is also eyeing AI, blockchain, data analytics, predictive tools and other applicable “alternative disruptive" platforms to automate large volumes of drug approval requests while ensuring systems security and promoting transparency in business transactions.

FDA added it wants to establish real-time performance monitoring systems, track regulatory oversight procedures, streamline communications, simplify records management and improve customer experience as part of the initiative.

The department plans to award a four-year contract for the effort as a follow-on to a blanket purchase agreement slated to conclude this fiscal year.

Responses to the RFI are due on June 2.

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