Episode 39 – New FDA Commissioner Dr. Califf: What His Appointment Means for the Regulated Industry and What to Watch for in 2022

Now that the US Senate has confirmed Dr. Robert Califf as Commissioner of the US Food and Drug Administration, a position he held briefly in the Obama Administration, we turn to the priorities and perspective he is likely to bring to the agency. Making big data, including from electronic health records, useful for research and sufficient to support FDA regulatory decision-making emerged as a major theme from Califf's Senate testimony. How might he employ big data to achieve his stated goals of improving emergency preparedness and response, modernizing the FDA, and ensuring the safety of FDA-regulated products already on the market? In this episode of Connected With Latham, New York partner Nathan Ajiashvili discusses this question and more with Washington, D.C.-based Healthcare & Life Sciences partners John Manthei, Global Chair of the practice, and Ben Haas, as well as associate Nathan Beaton.    This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200