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FDA Seeks to Invest in Foodborne Illness Prevention, Medical Product Safety and Countermeasures
Date:2/14/2011

apply new tools and standards to speed the development of MCMs. To improve public health response, FDA will also modernize the legal, regulatory and policy framework that governs development and availability of MCMs.
  • Protecting Patients Initiative ($124 million): With this increase, FDA will develop a pathway for approving biosimilars, which are biological drugs shown to be highly similar to, and without clinically meaningful differences with, an FDA-approved reference biological product. Such biosimilars may also be shown to be interchangeable with the FDA-approved reference biological product. These biosimilars offer the potential of significant savings for government and private sector healthcare systems that provide care to millions of Americans. The Protecting Patients Initiative also strengthens FDA efforts to modernize and improve safety throughout the supply chain of medical products, and it contains other resources to assure the safety of medical products.
  • Regulatory Science and Facilities Initiative ($49 Million): This request will allow FDA to strengthen its core regulatory scientific capacity that support all elements of the FDA mission. This initiative will help harness advances in science and technology to modernize and streamline the regulatory pathway and improve the review and approval process for products relying on new and emerging technologies that offer promising new opportunities to diagnose, treat, cure and prevent disease.

  • For more information:

    The President's FY 2012 budget for the FDA  

    Food Safety Modernization Act: Putting the Focus on Prevention

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    Media Inquiries: Jeff Ventura, 301-796-2807, jeffrey.ventura@fda.hhs.gov


    SOURCE U.S. Food and Drug Administration
    Copyright©2010 PR Newswire.
    All rights reserved

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