martes, 9 de diciembre de 2025

Webinars and Virtual Workshops

Webinars and Virtual Workshops General Hospital and Personal Use Devices Panel Meeting Announcement Date: Wednesday, Dec. 10, 2025; 9 a.m. - 3:30 p.m. ET On December 10, 2025, the Advisory Committee will meet virtually to deliberate and make recommendations on issues related to an emerging technology in the context of medical devices and germicidal ultraviolet (UV) light as a mode of disinfection. The FDA is seeking to obtain feedback to improve the total product life cycle (TPLC) evaluation of UV disinfection devices. In addition, the Committee will meet to discuss and provide advice to the FDA on devices used in pandemic preparedness and response to satisfy, in part, a requirement under the Food and Drug Omnibus Reform Act of 2022 (FDORA). https://www.fda.gov/advisory-committees/advisory-committee-calendar/updated-meeting-time-and-public-participation-information-december-10-2025-general-hospital-and?utm_medium=email&utm_source=govdelivery FDA Expert Panel on Testosterone Replacement Therapy for Men Date: Wednesday, Dec. 10, 2025; 1 - 3 p.m. ET FDA Expert Panels are roundtable discussions with independent panels of scientific experts that will review the latest scientific evidence, evaluate potential health risks, explore safer alternatives, and individual experts may offer their recommendations for regulatory action. This initiative is part of the FDA’s broader efforts to apply rigorous, evidence-based standards to modernize regulatory oversight, while considering evolving science and consumer health. The FDA Expert Panel on Testosterone Replacement Therapy for Men will facilitate discussions on the risks and benefits related to testosterone replacement therapy. https://www.fda.gov/patients/fda-expert-panels/fda-expert-panel-testosterone-replacement-therapy-men-12102025?utm_medium=email&utm_source=govdelivery Quality and Regulatory Predictability: Shaping USP Standards Date: Thursday, Dec. 11, 2025; 9 - 10:30 a.m. ET This discussion will show how USP public standards strengthen quality, streamline development, support regulatory compliance, and overall, increase regulatory predictability for drugs. Attendees will gain insights into the USP standards development process and learn how they can sponsor or participate—via public comment—in the development of future standards. https://www.surveymonkey.com/r/FDA_USP_AAM_251211?utm_medium=email&utm_source=govdelivery FDA Oncology Center of Excellence Presents Conversations on Cancer: “Empowered Choices: Perspectives on Cancer Care Decision-Making Among Older Adults” Date: Thursday, Dec. 11, 2025; 11 a.m. - noon ET As the global population ages, healthcare providers increasingly encounter unique challenges in tailoring cancer treatments for older patients. The landscape of cancer care for older adults is complex and multifaceted. It's where personal values and life experiences intersect with medical expertise and technological capabilities. The session will explore this intricate tapestry of decision-making in geriatric oncology, emphasizing patient-centered decision-making processes. Attend Online: https://www.youtube.com/live/vW7_8Az5AzQ FDA Grand Rounds – Advancing Real-World Evidence in FDA Regulatory Decision Making Date: Thursday, Dec. 11, 2025; noon - 1 p.m. ET This presentation will explore how the FDA is using real-world data (data routinely collected in clinical practice) to generate real-world evidence (RWE) to inform regulatory decisions about the effectiveness and safety of medical products. The lecture will cover the evolution of this approach, highlight key activities of the FDA's Real-World Evidence program, and showcase selected guidance documents and demonstration projects that are advancing how we evaluate medical products. FDA Employees Register Here Non-FDA Employees Register Here: https://events.gcc.teams.microsoft.com/event/f6cabafe-b5f5-4fd1-971c-3e255c7b9d75@7d2fdb41-339c-4257-87f2-a665730b31fc/registration?utm_medium=email&utm_source=govdelivery Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine Date: Tuesday, Dec. 16, 2025 - 9 a.m. - 4:30 p.m. ET This hybrid public workshop will initiate a discussion on expanding epinephrine accessibility and use, including in community settings, to reduce anaphylaxis-related morbidity and mortality. Register to Attend In-Person Register to Attend Virtually: https://duke.zoom.us/webinar/register/WN_UbhjWX4vTJ2buMZzEmk3YA?utm_medium=email&utm_source=govdelivery#/registration FDA and The American Society of Pediatric Hematology/Oncology (ASPHO) Pediatric Hematology/Oncology Educational Program Date: Application Deadline Monday, Dec. 29, 2025, 3 p.m. CT The FDA and ASPHO have partnered to cosponsor an 8-month interactive educational program designed for early career pediatric hematology/oncology clinicians and researchers. This program addresses a critical gap in training by providing learners with a foundational understanding of pediatric hematology/oncology drug-development and the regulatory review process. Apply Here: https://survey.alchemer.com/s3/8537777/FDA-ASPHO-PHO-Educational-Program?utm_medium=email&utm_source=govdelivery

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