FDA To Prioritize Regen Meds, Combo Products, Patient-Focused Initiatives

FDA's final work plan for its 21st Century Cures Innovation Account targets what the agency views as the highest priorities for enhancing patient access to therapies and information, including improving upon the Regenerative Medicine Advanced Therapy (RMAT) Designation and modernizing regulation of combination products. The plan also lays out how the agency will develop a qualification process for drug development tools, which the agency says could "transform drug development and review." Other efforts highlighted in the work plan include following...