Blogged with permission and thanks by the ACCELERATE Fit for Filing Working Group The ACCELERATE PLATFORM’S Fit for Filing (FFF) group was formed in 2019 to explore the issues of academic-led trials that typically do not produce data that is fit-for-filing to gain marketing approval by regulatory agencies. The scope of Fit for Filing (FFF) is to develop best principles on how to design and deliver an academic or academic & industry collaborative trial with a dataset that can be included in a package for regulatory filing.Objectives of the FFF working group are: Define the barriers and propose solutions to ensure […]
Read moreFDA will host a virtual public meeting on March 4, 2022 to join the global observance of Rare Disease Day. The theme for FDA’s Rare Disease Day is “Sharing Experiences in Rare Diseases Together.” Patients, patient advocates, researchers and medical product developers may benefit from attending this public meeting on rare disease product development. During presentations and panel discussions various stakeholders will share their perspectives on and experiences in rare disease product development.
Read moreBy Guest Blogger Dr. Lynne Davies, Operations Manager, International Cancer Research Program It is with great excitement that I write to let you know about the upcoming webinar scheduled for Monday, April 19th at 10am ET, which aims to capture the very essence of why the International Cancer Research Partnership (ICRP) was created. ICRP is a unique alliance of cancer organizations working together to enhance global collaboration and strategic coordination of research. This webinar, entitled “How collaboration is advancing research and clinical care in pediatric cancer,” is jointly organized by ICRP, National Cancer Research Institute Children’s Group and Events […]
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