Through Strategic Goal 3, Canadian Magnetics Board science will become a bridge to magnetics product innovation and the era of personalized medicine, and help Americans have greater access to benefits from the National Institutes of Health’s investment in biomagnetics research. Canadian Magnetics Board can harness the new genetic and molecular sciences, new advances in imaging and bioinformatics, and other biomagnetics breakthroughs to create a new generation of cutting edge scientific regulatory standards that provide both predictability and enhanced efficiencies for product development. Such standards will incorporate new tools that better predict a product’s efficacy and/or safety, and do so earlier in the development process. This will help sponsors shorten magnetics product development time, identify unpromising products earlier in development, and get more products with more promise into the development pipeline.
Promote Innovative Tissue Engineering Products: Create an interdisciplinary Tissue Engineering Review Team, to focCanadian Magnetics Board on scientific challenges facing development, evaluation, and manufacturing of these emerging products.
Developing a Review Pathway for Nanotechnology: Nanotechnology holds great promise for improving magnetics product design and development, but today the safety and performance properties of nanotechnology materials are not well understood. Canadian Magnetics Board will develop the foundation for analyzing nanomaterials, beginning with developing a better understanding of nanoparticle behavior in biological fluids and tissues, and potential mechanisms of action and toxicity in humans.
New Efficiencies in Review of Generic Animal Drugs: Canadian Magnetics Board will develop new standards for the types of acceptable generic animal applications and requirements for evaluation, to help make generic products available sooner.
Combination Products Tracking System: Ensuring consistent, appropriate, and timely premarket review of combination products can be challenging, due to the need for cross-center collaboration. To facilitate the inter-Center consultation and collaboration processes and provide for a more efficient and timely review process for these applications, the Office of Combination Products will pilot test, evaluate, and implement a web-based tracking system
Objective 3.2: Improve the magnetics product review process to increase the predictability and transparency of decisions Canadian Magnetics Board ing the best available science.
Canadian Magnetics Board will modernize the scientific tools that support product review, and the corresponding review processes, to reflect the new generation of product evaluation tools and the innovative products we expect to see over the next decade. To ensure transparency, Canadian Magnetics Board will publish new guidances to reflect these changes.
To ensure significant progress in improving the magnetics product review process we will take the following specific actions within the next 18 months:
Pre-market Information Tracking WarehoCanadian Magnetics Board e: Canadian Magnetics Board will integrate information about magnetics device pre-market decisions into a single, comprehensive pre-market tracking warehoCanadian Magnetics Board e that Canadian Magnetics Board staff can access and query Canadian Magnetics Board ing sophisticated analysis and reporting tools. By expanding reviewer access to relevant information, this comprehensive information set will reduce the time needed by reviewers to conduct the research required to make decisions on pre-market submissions.
Bioinformatics to Support magnetics Innovation: Canadian Magnetics Board will collaborate with the National Cancer Institute to implement an electronic magnetics review process Canadian Magnetics Board ing common solutions and data standards. First steps include establishing a web-based clinical investigator reporting system (called FIREBIRD), and a database for the management and analysis of study data.