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Articles by Jami Fogelhut
Health Law Daily Wrap Up , EXPERT INSIGHTS—FDA opens applications for new pilot to shorten drug approval times: What sponsors need to know , (Oct 15, 2026)
By Justine Lei and Jami Fogelhut of Sheppard, Mullin, Richter & Hampton LLP Earlier this month, FDA opened applications for a new Expedited Investigational New Drug (IND) Pilot Program (the "Program"), an initiative launched under HHS Operation TrialBlazer[1] that aims to shorten the path from IND-enabling activities to first-in-human (FIH) trials while preserving FDA's existing safety and scientific review standards.
FDA Opens Applications For New Pilot To Shorten Drug Approval Times: What Sponsors Need To Know
Earlier this month, FDA opened applications for a new Expedited Investigational New Drug (IND) Pilot Program (the “Program”), an initiative launched under HHS Operation TrialBlazer1 that aims to shorten the path from IND-enabling activities to first-in-human (FIH) trials while preserving FDA’s existing safety and scientific review standards.
FDA Opens Applications for New Pilot to Shorten Drug Approval Times: What Sponsors Need to Know
Earlier this month, FDA opened applications for a new Expedited Investigational New Drug (IND) Pilot Program (the "Program"), an initiative launched under HHS Operation TrialBlazer[i] that aims to shorten the path from IND-enabling activities to...
Testing The Boundaries Of Artificial Intelligence In Care Delivery: Utah's Prescription Renewal Pilot Program
Sheppard, Mullin, Richter & Hampton LLP are most popular: within Insolvency/Bankruptcy/Re-Structuring and Cannabis & Hemp topic(s) In January 2026, the State of Utah, acting through its Department of Commerce's Office of Artificial Intelligence Policy ("OAIP"), launched a first-in-the-nation pilot permitting an autonomous artificial intelligence ("AI") system developed by Doctronic, a healthcare AI platform, to participate in prescription medication renewals for patients with chronic...
Testing the Boundaries of Artificial Intelligence in Care Delivery: Utah’s Prescription Renewal Pilot Program | JD Supra
In January 2026, the State of Utah, acting through its Department of Commerce’s Office of Artificial Intelligence Policy (“OAIP”), launched a first-in-the-nation pilot permitting an autonomous artificial intelligence (“AI”) system developed by Doctronic, a healthcare AI platform, to participate in prescription medication renewals for patients with chronic conditions.[1] The pilot initiative represents a significant departure from traditional state medical practice controls by enabling an AI...
Testing the Boundaries of Artificial Intelligence in Care Delivery: Utah's Prescription Renewal Pilot Program
In January 2026, the State of Utah, acting through its Department of Commerce's Office of Artificial Intelligence Policy ("OAIP"), launched a first-in-the-nation pilot permitting an autonomous artificial intelligence ("AI") system developed by...
Utah Enacts AI Amendments Targeted At Mental Health Chatbots And Generative AI
Listen to this post Utah is one of a handful of states that has been a leader in its regulation of AI. Utah's Artificial Intelligence Policy Act1 ("UAIPA") was enacted in 2024 and requires disclosures relating to consumer interaction with generative AI with heightened requirements on regulated professions, including licensed healthcare professionals.
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