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Download The Accelerating Decline In America\'s High Skilled Workforce: Implications For Immigration Policy

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  • create individualized orphan product strategies that include guidance on regulatory strategy and feasibility of drug development, scientific review of proposed drug repurposing plans, evaluation of clinical study design, and trouble-shooting regulatory and development issues
  • author and review applications for orphan drug designations, pediatric rare disease designation vouchers, breakthrough therapy designations, and other expedited review applications
  • develop materials for meetings with the FDA and EMA and assist with meeting preparations
  • facilitate connections with patient advocacy groups and key opinion leaders
  • interpret policies and communications from regulatory agencies around the world
Athens: Ohio University Press, 2006. 95( ©), ISBN 978-0-8214-1675-4. debated by Ralph Bauer( University of Maryland, College Park)Published on H-Amstdy( April, available by Kelly J. Manhood in the Age of Aquarius: light in Two Countercultural Communities, 1965-1983. New York: Columbia University Press, 2007.
  • develop and implement policy initiatives
  • identify the right pharmaceutical company to “adopt” a product
  • navigate the biotech and regulatory communities
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