FDA Roundup: May 21, 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 that registration is open for the two-day virtual public meeting, "FDA’s Fifth Online Controlled Substances Summit." The goal of this summit, hosted in partnership with the Reagan-Udall Foundation for the FDA, is to identify innovative solutions to reduce the illegal availability of controlled substances online. Day one of the summit will be a public session with FDA leadership, including Commissioner Robert Califf, and other experts that will examine the impact and evolution of online purchases of controlled substances, as well as review progress that has been made since last year's summit. Day two is an invitation-only working session that will engage social media, internet, technology and controlled substances experts in intensive planning and evaluation to identify immediately implementable actions as well as long-term strategies that aim to disrupt the trajectory of the current crisis.
• Today, the FDA announced it is extending the comment period for the proposed rule entitled “Labeling Requirements for Approved or Conditionally Approved New Animal Drugs” by 60 days. The agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. Either electronic or written comments must be submitted by August 9, 2024.
• On Monday, the FDA approved the first two interchangeable biosimilars to Eylea (aflibercept), Yesafili (aflibercept-jbvf) and Opuviz (aflibercecpt-yszy). Aflibercept products work by inhibiting vascular endothelial growth factors (VEGF) and preventing new or abnormal blood vessel growth within the eye. By blocking VEGF, these products can help to slow down or reduce damage to the retina and preserve vision. Additional information about these medications, including their risks and side effects, can be found at the CDER notable approval webpage.
• On Monday, the FDA published the FDA Voices: “FDA Promotes Clinical Trial Innovation,” by Hilary Marston, MD, MPH, Chief Medical Officer and Kevin Bugin, PhD, Deputy Director of Operations in the Office of New Drugs, Center for Drug Evaluation and Research. As the FDA observed Clinical Trials Day yesterday, we reflected on the progress made and the widespread efforts underway to advance clinical trial innovation. This progress has been possible because of clinical trial participants and their families, health care professionals, medical product developers, federal partners and the entire clinical research community.
• On Monday, the FDA announced a public workshop, Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products. The purpose of the workshop is to discuss transplacental transfer of drug and biological products with immunosuppressive properties and the potential clinical impact on the developing fetus and newborn infant, understand the gaps in knowledge, and consider innovative approaches to improve collection of relevant data. The workshop will be held July 11 and 12 on-site at FDA’s White Oak Campus (Silver Spring, MD) and virtually. Registration is required for both online and on-site attendance. 
• On Monday, the FDA Oncology Center of Excellence (OCE) announced the formation of The OCE Equity Program. The new program expands Project Equity, continuing the OCE’s work to improve access to clinical trials of oncology medical products for populations that have been historically underrepresented in clinical research. The OCE formed Project Equity in 2021 to focus the OCE’s longstanding efforts to address the well-documented underrepresentation of racial and ethnic subgroups in clinical trials. In addition to racial and ethnic minorities, the OCE Equity Program will continue the OCE’s efforts to improve trial access for individuals who live in rural areas, sexual and gender minorities, and individuals with economic, linguistic, or cultural barriers to healthcare services.  
• On Monday, the FDA announced the launch of the Center for Devices and Radiological Health and Office of Digital Transformation’s precisionFDA Phase 1 of the Digitally-Derived Endpoints for Freezing-of-Gait Detection Challenge on May 28, 2024. The Challenge seeks artificial intelligence (AI) models to identify and predict digitally-derived endpoints for freezing of gait events related to Parkinson’s disease. Medical device developers, tech innovators, software developers, and academic researchers are invited to participate. Register to participate in the challenge today and submit AI models before August 2, 2024.

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