FDA Revises Trial Requirements for Drug and Medical Product Approval - Part 1

In part one of this series, Dr. Justin Abbatemarco and Lizzy Lawrence discuss the FDA's shift toward single-trial drug approvals.  Show citation:  https://www.statnews.com/2025/12/04/fda-considers-single-clinical-trial-for-new-product-approvals/ 

Dr. Halley Alexander and Dr. Mikael Guzman Karlsson discuss the development and evaluation of an AI-enabled clinical assistant designed to support time-sensitive decision-making in neurology. View the related abstract:  https://index.mirasmart.com/AAN2026/PDFfiles/AAN2026-003409.html 

In part two of this series, Dr. Tesha Monteith and Dr. Nimish A. Mohile discuss the motivation behind the development of this roadmap to neurological health equity.  Show citation:  Patel PB, Hamilton RH, Budhu JA, et al. A Roadmap to Neurologic Health Equity: An AAN Position Statement. Neurology. 2026;106(5):e214687. doi:10.1212/WNL.0000000000214687 

In the first part of this series, Dr. Tesha Monteith and Dr. Nimish A. Mohile discuss what the roadmap is and how it is intended to benefit practicing neurologists. Show citation:  Patel PB, Hamilton RH, Budhu JA, et al. A Roadmap to Neurologic Health Equity: An AAN Position Statement. Neurology. 2026;106(5):e214687. doi:10.1212/WNL.0000000000214687   

Dr. Greg Cooper and Dr. Sara Hassani discuss periprocedural brain health and call on neurologists to engage in multidisciplinary efforts to improve periprocedural outcomes. Show citation: Hassani S, Gorelick PB. Periprocedural Brain Health: The Scope of the Problem and the Neurologist's Role. Neurology. 2025;105(12):e214427. doi:10.1212/WNL.0000000000214427   Show transcript: Dr. Greg Cooper: Hi, this is Greg Cooper. I just finished interviewing Sara Hassani for this week's Neurology Podcast. For today's Neurology minutes, Sara, I'm hoping you can tell us the main points of your paper. Dr. Sara Hassani:  I would say that the central message of this paper is that paraprocedural neurologic complications, they're very common, and they may actually be as high as the third leading cause of mortality, and yet very few healthcare providers realize this. And furthermore, few healthcare providers are adequately prepared to discuss the risks of the various procedures with patients and/or their family members. Dr. Greg Cooper: Thank you for that summary and all your work on this topic. Please check out this week's podcast to hear the full interview, and read the full article published in Neurology, Paraprocedural Brain Health. Thank you. 

Dr. Paul Crane and Dr. Hanalise Huff discuss neurological and neurocognitive sequelae in pediatric survivors of the 2015 Ebola outbreak in Liberia.  Show citation:  Huff HV, Van Ryn C, Reilly C, et al. Neurologic Sequelae After Ebola Virus Disease in Children in Liberia: An Observational Study. Neurology. 2026;106(1):e214450. doi:10.1212/WNL.0000000000214450 

In this lab update, Dr. Stacey Clardy focuses on micronutrient screening. 

In this lab update, Dr. Stacey Clardy discusses the latest information on chronic wasting disease. 

In part two of this series, Dr. Aaron Zelikovich discusses the clinical implications for patients with HSV encephalitis.  Show citation:  Solomon T, Hooper C, Easton A, et al. Safety and efficacy of adjunct dexamethasone in adults with herpes simplex virus encephalitis in the UK (DexEnceph): a multicentre, observer-blind, randomised, phase 3, controlled trial. Lancet Neurol. 2026;25(2):136-146. doi:10.1016/S1474-4422(25)00454-5 

Dr. Greg Cooper and Dr. Kerry Sheets discuss how hearing aid use affects cognition and the risk of dementia in older adults with hearing impairment.  Show citations: Cribb L, Moreno-Betancur M, Pase MP, et al. Treating Hearing Loss With Hearing Aids for the Prevention of Cognitive Decline and Dementia. Neurology. 2026;106(3):e214572. doi:10.1212/WNL.0000000000214572  Show transcript: Dr. Greg Cooper: Hi, this is Greg Cooper. I just finished interviewing Kerry Sheets for this week's Neurology Podcast. For today's Neurology Minute, I'm hoping you can tell us the main points of your paper. Dr. Kerry Sheets: The central message of our paper is that hearing aid use in adults aged 70 years or older with hearing impairment may reduce dementia risk over 7 years. Results for the impact of hearing aid use on cognitive decline were less. Dr. Greg Cooper: Well, thank you for that summary and for all of your work on this topic. Please check out this week's podcast to hear the full interview and read the full article published in Neurology: Treating Hearing Loss with Hearing Aids for the Prevention of Cognitive Decline and Dementia.