Research and Markets(http://www.researchandmarkets.com/research/36d418/regulatory_and_leg) has announced the addition of Decision Resources, Inc.'s new report "Regulatory and Legislative Activities: Shaping Biomarker and Diagnostic Use and Driving Personalized Medicine" to their offering.
“Regulatory and Legislative Activities: Shaping Biomarker and Diagnostic Use and Driving Personalized Medicine”
Introduction Successful navigation of the regulatory maze is a prerequisite for companies using biomarkers and diagnostics to advance personalized medicine. U.S., European, and Japanese regulators recognize the critical role they play and are reaching out to the industry by publishing guidance and requesting commentary. Additionally, recent legislation, such as GINA, is giving companies new opportunities to further their efforts in personalized medicine. However, plenty of barriers still exist: some are intrinsic to regulatory processes, while others relate to the interpretation of regulations. Industry players are exploring a variety of approaches to overcome these challenges.
Questions Answered in This Report
A host of regulatory decisions and deadlines are occurring right now. How will GINA (signed into law in May 2008) influence clinical trial enrollment and purchasing of personal genetics products once it fully takes effect in November 2009? What impact will the imminent final report on gene patents by the SACGHS have on licensing practices and patient access to genetic tests? What will the results of the Navigenics/Mayo Clinic study on predictive genetic risk assessments reveal when the study completes in December 2009? What will be the outcome of the August 2009 announcement by the EMEA to clarify criteria used to evaluate in vivo diagnostic tests, taking effect on February 1, 2010? How will Japan's PMDA adhere to the action plan it set forth in April 2009 to enable shorter review times of diagnostics?