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.
Thomas Cosgrove
Tom Cosgrove is a partner in Covington’s Food, Drug and Device Practice Group. He joined Covington in 2017 from the Food and Drug Administration (FDA), where he was a senior official charged with ensuring the quality of drugs and therapeutic biologics marketed to U.S. patients. Tom brings a wealth of experience to bear in helping clients navigate the complex world of pharmaceutical compliance and enforcement in the United States and around the globe.
At FDA, Tom held senior leadership positions within the Office of Compliance in the Center for Drug Evaluation and Research (CDER), including leading the organization as Acting Director in 2016. Beginning in 2014, he led the Office of Manufacturing Quality (OMQ), where he was responsible for CDER’s enforcement activities covering current good manufacturing practice (CGMP) and drug quality. In this role, Tom was responsible for setting FDA’s CGMP enforcement priorities and for clearing warning letters, import alerts, and referrals for civil and criminal enforcement. He also played a central role in the FDA's deliberations concerning the approval of marketing applications submitted by companies with manufacturing compliance challenges.
As Acting Director of CDER Compliance in 2016, Tom oversaw OMQ as well as the offices responsible for enforcing FDA’s requirements for drug approval and labeling, human drug compounding, drug supply chain security and integrity, and clinical trials and bioequivalence studies.
He is a frequent speaker at conferences and trainings focused on drug quality, compliance, and enforcement at home and abroad.
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