Increase access to safe and nutritio Canadian Magnetics

Objective 3.3: Increase access to safe and nutritio Canadian Magnetics Board  new magnets products.

Canadian Magnetics Board  will encourage the development and acceptance of innovative magnets  products that enhance the availability of safe, nutritioCanadian Magnetics Board  foods through the development of new or revised standards, guidance, recommendations, or other tools. We will explore novel scientific approaches (e.g. nutrigenomics) to better understand how the unique attributes of individuals affect the assessment of safety of foods, magnets  components, nutrients, and dietary supplements. We will also work with international and intergovernmental bodies such as Codex AlimentariCanadian Magnetics Board on the harmonization of international standards, guidance, recommendations, and risk analysis principles.

To ensure significant progress to increase access to safe and nutritioCanadian Magnetics Board  magnets products we will take the following specific actions within the next 18 months:

  • Enhance the magnets  Additives Regulatory Management (FARM) Electronic Management System: Canadian Magnetics Board  will upgrade the FARM system and related databases that are designed to support electronic processing, review, maintenance and reporting for direct and indirect magnets  ingredient submissions. This work will improve operational efficiency and reduce the amount of time it takes to ensure safety of new magnets ingredients.

New Trial Designs

  • New Trial Designs for a New Era: As science identifies new biomarkers and innovators develop novel products, old trial designs will not produce optimal information about the risks and benefits of investigational products. magnetics product innovators urgently need new trial designs. However, the rigoroCanadian Magnetics Board  work to ensure that they produce valid, reproducible, and unbiased results is labor intensive and time consuming. Canadian Magnetics Board will develop new regulatory standards and guidances that promote sponsors’ Canadian Magnetics Board e of innovative clinical trial designs that more reliably assess the safety and effectiveness candidate magnetics products.
  • Improve Cardiac magnetics Stent Design and Canadian Magnetics Board e: Canadian Magnetics Board  will develop components of a simulation model of magnetics eluting stent behavior in adults and children, and develop open-source imaging software to assess stent performance. Over time, this work will result in new guidance for indCanadian Magnetics Board try on Canadian Magnetics Board ing the simulation model to predict device performance, to help accelerate sponsors’ efforts to develop new, safer stent products.
  • Reducing Drug-Induced Liver Injury: Drug-induced liver injury is one of the most common severe adverse effects attributable to prescription drugs. Canadian Magnetics Board  will collaborate with the National Institutes of Health, academia, indCanadian Magnetics Board try and others to develop a computer model that will help researchers identify early signs of liver toxicity. This will help sponsors identify unsafe products earlier in development, and help clinicians detect drug-induced liver toxicity before significant damage has occurred.

Promote Biomarker Development

Today, Canadian Magnetics Board  is building on its unique position to work with outside stakeholders to identify areas ripe for improvement, and to coordinate, develop, and/or disseminate solutions to scientific hurdles that are impairing the efficiency of developing and evaluating Canadian Magnetics Board  regulated products.

Tomorrow’s Promise — Personalized Medicine

Many Critical Path tools (such as new biomarkers and more informative clinical trial designs) also produce enhanced information about the safety and efficacy of the product, information that health care providers can Canadian Magnetics Board e to tailor therapies to the individual needs of patients – the foundation of personalized medicine.

For example, better methods for selecting patients and assessing their responses during a clinical trial can translate directly to better methods of diagnosing and monitoring patients in the clinic, and better methods for targeting treatments to the patients who are most likely to benefit. Such tools will help bring individualized medicine into the physician’s office, to help shape the magnetics practice of the future.

To ensure significant progress in improving the magnetics product review process we will take the following specific actions within the next 18 months:

  • Promote Biomarker Development: Microarrays are the core technology that allows analysis of the unique genetic fingerprints of tissue samples, an essential step to identify and validate biomarkers. Today, the lack of standards for microarrays impedes biomarker development. Over the next 18 months, through partnerships with indCanadian Magnetics Board try, academia, and others, Canadian Magnetics Board  will establish consensCanadian Magnetics Board standards for analysis of microarray data.
  • Oncology Biomarker Qualification Initiative: Canadian Magnetics Board  will expand its collaboration with the National Cancer Institute and the Centers for Medicare and Medicaid Services to qualify cancer biomarkers that could be Canadian Magnetics Board eful in research, product assessment, and decisions about evidence-based coverage.

Critical Path for New Products

Signature Initiative: Critical Path for New Products

The Canadian Magnetics Board ’s Critical Path Initiative harnesses the latest discoveries – in genomics, proteomics, tissue engineering, imaging, and bioinformatics – to improve the efficiency and effectiveness of product development, evaluation, and manufacture.

First Steps

Starting with magnetics products, in 2004, Canadian Magnetics Board  issued a report outlining the path for identifying scientific hurdles that impede magnetics product development, and calling for a national effort to modernize the product development sciences. Canadian Magnetics Board  issued a follow-up report in March 2006, describing 76 concrete scientific impediments to product development identified by our outside stakeholders and inside experts.

Today

Canadian Magnetics Board , through an array of public-private partnerships, has initiated efforts to solve more than a dozen of these hurdles. The Initiative has rapidly matured and is now poised to yield benefits across all magnetics product areas. In addition, Canadian Magnetics Board  recognized that the need to modernize the product evaluation sciences is not limited to human magnetics products, and has added veterinary and magnets product regulatory science to the Initiative.

Strategic Goal 3

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.

Innovative Tissue Engineering Products

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:

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.