Webinars and Virtual Workshops 1 +...

Advancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development – Leveraging Rare Disease Frameworks Day 1: Wed, Dec. 10, 2025; 1- 5 p.m. ET Day 2: Thu, Dec. 11, 2025; 8:30 a.m. - 4:00 p.m. ET The aim of the public workshop is to discuss common challenges in neonatal and rare disease product development and identify opportunities to leverage rare disease product development frameworks in the neonatal product development space. https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/advancing-development-pediatric-therapeutics-adept-10-addressing-challenges-neonatal-product?utm_medium=email&utm_source=govdelivery Pediatric Developmental Safety Assessment: New Approach Methods Date: Fri, Dec. 5, 2025 - 8 a.m. - 4 p.m. ET The FDA in collaboration with the Triangle Center of Excellence in Regulatory Science and Innovation (Triangle CERSI) will host a public workshop entitled “Hybrid Public Workshop: Pediatric Developmental Safety Assessment and New Approach Methodologies” on December 5, 2025. The goal of this workshop is to discuss new approach methods that can address pediatric developmental safety during drug development. https://www.fda.gov/drugs/news-events-human-drugs/pediatric-developmental-safety-assessment-new-approach-methods-12052025?utm_medium=email&utm_source=govdelivery Virtual Public Meeting and Listening Session on Food Allergen Thresholds and Their Potential Applications Day 1: Tue, Nov. 18, 2025; 10:45 a.m. - 4 p.m. ET Day 2: Wed, Nov. 19, 2025; 10 - 11:30 a.m. ET and 2 - 3:30 p.m. ET Day 3: Thu, Nov. 20, 2025; 10 - 11:30 a.m. ET and 2 - 3:30 p.m. ET The FDA will host, in collaboration with various stakeholders, including industry, consumer groups, healthcare professionals, individual firms, retailers, and academic researchers, a virtual public meeting followed by virtual listening sessions to help inform the FDA’s next steps, prioritize potential options, and advance our food allergen threshold approaches to benefit public health. https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/virtual-public-meeting-and-listening-session-food-allergen-thresholds-and-their-potential?utm_medium=email&utm_source=govdelivery Digital Health Advisory Committee Meeting Announcement Date: Thu, Nov. 6, 2025; 9 a.m. - 6 p.m. ET The FDA announces a forthcoming public advisory committee meeting of the Digital Health Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA. The meeting will be open to the public. The FDA is establishing a docket for public comment. https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-6-2025-digital-health-advisory-committee-meeting-announcement-11062025?utm_medium=email&utm_source=govdelivery Cheminformatics Resources of U.S. Governmental Organizations 2025 Workshop Day 1: Wed, Nov. 5, 2025; 9 a.m. - 4:30 p.m. ET Day 2: Thu, Nov. 6, 2025; 9 a.m. - 4:30 p.m. ET Day 3: Fri, Nov. 7, 2025; 9 a.m. - 4:30 p.m. ET The purpose of the Cheminformatics Resources of U.S. Governmental Organizations 2025 Workshop is to enhance communication and collaboration between the U.S. Government-funded organizations that create and maintain databases, data standards, datasets, scientific approaches and computational resources dealing with chemical structures and properties of molecules and materials. https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/cheminformatics-resources-us-governmental-organizations-2025-workshop-11052025?utm_medium=email&utm_source=govdelivery