Virtual Public Workshop – Accreditation Scheme for Conformity Assessment Expansion - April 17, 2024 APRIL 17, 2024 +++

https://www.fda.gov/medical-devices/medical-devices-news-and-events/virtual-public-workshop-accreditation-scheme-conformity-assessment-expansion-april-17-2024-04172024?utm_medium=email&utm_source=govdelivery CDRHNew - News and Updates https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrhnew-news-and-updates LEADER 3D: Learning and Education to Advance and Empower Rare Disease Drug Developers PUBLIC REPORT OF EXTERNAL STAKEHOLDER ANALYSIS https://www.fda.gov/media/176557/download?attachment=&utm_medium=email&utm_source=govdelivery Now Available: LEADER 3D Public Report of External Engagement Analysis As we observe Rare Disease Week 2024, CDER is pleased to announce the release of the Learning and Education to Advance and Empower Rare Disease Drug Developers (LEADER 3D) Public Report of External Stakeholder Analysis. The Accelerating Rare disease Cures (ARC) Program initiated LEADER 3D to better understand the unique challenges in bringing rare disease products to market, such as challenges related to nonclinical studies, dose-finding, natural history studies and registries, novel endpoint and biomarker development, clinical trial design and analysis, and regulatory considerations. As part of LEADER 3D, CDER’s Rare Diseases Team worked with an independent contractor to conduct interviews with the rare disease drug development community and performed a review of public docket comments to identify educational opportunities across topics of interest in rare disease drug development. This new report summarizes findings from the analysis of these interactions and provides recommendations for continued efforts to expand outreach and education for those involved in rare disease drug development. We want to thank the rare disease drug development community for their continued engagement in achieving the ARC Program mission to accelerate the availability of drug and biologic products for patients with rare diseases.