May 7, 2024 - FDA Roundup: May 7, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA announced a meeting of the Psychopharmacologic Drugs Advisory Committee on June 4 to discuss a new drug application for midomafetamine (MDMA) capsules, submitted by Lykos Therapeutics, for the treatment of post-traumatic stress disorder. The committee will discuss the overall benefit-risk profile of the product, including the potential public health impact.
  
  The FDA and invited participants may attend the meeting in-person at the FDA White Oak Campus. The public will have the option to participate via an online teleconferencing and/or video conferencing platform (Zoom). 
• Today, the FDA announced a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee on June 10 to discuss the biologics license application for donanemab, submitted by Eli Lilly and Company, for the treatment of early symptomatic Alzheimer’s disease. 
  
  FDA and invited participants may attend the meeting in-person at the FDA White Oak campus. The public will have the option to participate via an online teleconferencing and/or video conferencing platform (Zoom). 
• Today, the FDA’s Center for Biologics Evaluation and Research (CBER) is announcing that the May 16, 2024, meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) is being rescheduled to June 5, 2024.  The meeting, at which the Committee will discuss and make recommendations on the selection of strain(s) to be included in the 2024-2025 Formula for COVID-19 vaccines, is being moved to a later date to allow for additional time to obtain surveillance data and other information on recently circulating strains and to ensure that committee members will have more up-to-date information when making their recommendations. The agency does not anticipate that the date change will impact the availability of COVID-19 vaccines for the Fall vaccination campaign. The FDA’s priority is to ensure that the vaccines available in the U.S. are most appropriate to be used for the strain(s) anticipated to be circulating at the time the Fall respiratory virus vaccination campaign takes place. The web page for the meeting will be updated with the new date as soon as possible.
• On Monday, the FDA and the National Institutes of Health (NIH) published a request for information seeking public comments on a proposed glossary of clinical research terminology. This glossary is intended to facilitate communication within the clinical research community, by helping establish a common vocabulary to more uniformly characterize clinical research. The FDA and the NIH identified and developed definitions for 37 terms related to innovative clinical study designs. The public comment period will be open for 45 days. 
• On Monday, the FDA announced a webinar that will be held on Tuesday, May 14, 2024, from 1-2 p.m. ET to discuss the final rule “Medical Devices; Laboratory Developed Tests” (LDTs). During the webinar, the FDA will provide an overview of the final rule amending the FDA’s regulations to make it explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act including when the manufacturer of the IVD is a laboratory; and describe the phaseout of the FDA’s general enforcement discretion approach for LDTs.
• On Sunday, the FDA Oncology Center of Excellence (OCE) launched the Project 5 in 5 crowdsourcing initiative. OCE is using this initiative to provide an opportunity for the oncology community to submit ideas for important questions in oncology that may be answered over the next 5 years using pragmatic clinical trials.
  
  Traditional prospective randomized controlled trials in oncology are typically associated with significant monitoring, assessments, tests, and clinical follow-up visits that can be burdensome to trial participants, investigators, and sponsors. Pragmatic trials may be designed to be more reflective of routine clinical practice and aim to collect only information that is necessary to answer the research question. 
  
  Submissions to Project 5 in 5 can be made through July 5, 2024. Visit OCE's Crowdsourcing site for more information about how to submit your questions and to see examples of ideas that are invited. All submissions and discussions on the site will be moderated by FDA staff. 

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