RUF projects support the FDA while incorporating voices of all stakeholders, including FDA, patients and consumer advocates, regulated industry, healthcare providers, academics, and others – with the ultimate goal of improving public health. Some areas of work currently in development are outlined below.
Food Safety Innovation Consortium (FSIC)
The FSIC is a partnership to advance regulatory science in the area of food safety. Creation of the FSIC provides a much-needed venue for fostering collaboration between the FDA, other federal agencies, academia, industry and consumer advocates, with the goal of developing and executing a research agenda with both short-term and long-term priorities focused on shared needs. This initiative would serve to create a home-base to foster innovation and collaboration on food safety issues, with the goal of improving food safety and reducing foodborne illness. Read more about the proposed FSIC here.
Expanded Access (EA) Navigator
The EA Navigator would serve as a coordinated resource for clear information to help patients and healthcare providers navigate the EA request process, also known as compassionate use. The focus of the EA Navigator would be (non-emergency) individual patient access to investigational drugs (“single patient INDs”). Read more about the proposed EA Navigator here.
Regulatory Science Education & Fellowships
This work area aims to address the critical need for strengthening scientific capability and capacity, both within the FDA as well as externally. RUF is currently in the process of defining and developing our regulatory science education agenda. Ultimately, this will include work to foster greater understanding of and expertise in new scientific tools, diagnostics, and manufacturing techniques, and will serve to identify potential barriers to translating basic research into clinical and regulatory practice.