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Paula Katz

Paula Katz is a regulatory attorney with nearly 20 years of experience in pharmaceutical and medical products compliance and enforcement matters. Prior to joining the firm, Paula was the Director of Guidance and Policy in FDA's Center for Drug Evaluation and Research, Office of Manufacturing Quality. At FDA, Paula was responsible for development of current good manufacturing practice (CGMP) and drug quality policy and served as a clearing official on drug quality compliance actions. Paula brings her years of FDA experience to bear in providing clients with practical advice on a wide range of regulatory compliance and enforcement issues, including managing and responding to regulatory inspections, quality and safety reporting, regulatory outreach, product recalls, and investigations. She also routinely advises on regulatory aspects of commercial agreements and life sciences transactions and provides critical subject matter expertise to support commercial and government litigation and investigations.

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On March 23, 2023, FDA released a Framework for the use of digital health technologies in drug and biological product development (the “DHT Framework”).  This DHT Framework is on the heels of a Discussion Paper the Agency released earlier this month on the use of artificial intelligence (AI) in drug manufacturing to seek public input on issues of critical focus (the “AI Discussion Paper”).  While both actions are significant, the AI Discussion Paper is one of CDER’s few policy statements related to the deployment of AI around regulated activities (though the Center did establish an AI steering committee in 2020).  CDRH, on the other hand, has issued several policy documents around AI-based software potentially regulated as “software as a medical device” (SaMD), including through an April 2019 discussion paper that proposed a regulatory framework for modifications to AI-based SaMD, an AI “Action Plan” for SaMD in January 2021, and guiding principles to inform the development of Good Machine Learning Practice for AI-based medical devices in October 2021.  CDER has requested public comment on the recent DHT Discussion Paper and AI Framework by May 1 and 23, respectively.Continue Reading FDA Seeks Comments on Agency Actions to Advance Use of AI and Digital Health Technologies in Drug Development