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ADVENTRX Applauds Inclusion of Rare Diseases Provisions in the FDA Safety and Innovation Act
Date:7/11/2012

SAN DIEGO, July 11, 2012 /PRNewswire/ -- This week the Food and Drug Administration Safety and Innovation Act (Act) was signed into law.  The Act amends the Federal Food, Drug, and Cosmetic Act in a variety of ways that encourage or facilitate the development of drugs for patients with rare diseases, including: 

  • Establishment of a Rare Pediatric Disease Priority Review Voucher Incentive Program.  Entitles the sponsor of a "rare pediatric disease application" to a "priority review voucher" upon approval of the application.  The voucher, which can be transferred (including by sale), entitles the holder to priority (6-month) review of a new drug application.  Among other requirements, the rare pediatric disease application must target a rare pediatric disease, meaning a disease that primarily affects individuals from birth to 18 years and that is a rare disease or condition. 
  • Expansion of the Accelerated Approval framework.  Encourages FDA to implement more broadly effective processes for expedited development and review of innovative new medicines intended to address unmet medical needs for serious or life-threatening diseases or conditions, including those for rare diseases or conditions, using a broad range of surrogate endpoints, which may result in fewer, smaller or shorter clinical trials.  Enhances the statutory authority of FDA to consider appropriate scientific data, methods and tools, and to expedite development and access to novel treatments, for patients with a broad range of serious or life-threatening diseases or conditions.  Specifically authorizes approval decisions to take into account the severity and rarity of the condition and the lack of alternative treatments. 
  • Increased Consultation between FDA and External Experts on Rare Diseases.  For the purpose of promoting the efficiency of and informing the review b
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SOURCE ADVENTRX Pharmaceuticals
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