Innovative Systems for Delivery of Drugs and Biologics: Regulatory Challenges

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Innovative Systems for Delivery of Drugs and
BiologicsRegulatory Challenges

• Patricia B. Shrader
• AdvaMed
• July 8, 2003

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FDAs Questions

• What are the most critical challenges in
  developing and bringing to market a novel,
  innovative technology for delivery of drugs or
  biologics?
• What areas are most important for the Agency to
  provide guidance to developers of such novel
  products?
• How can the Agency best collaborate with
  industry, academia, other government agencies,
  and other scientific bodies in this area?

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1.) What are the most critical challenges

• Jurisdiction/Primary Mode of Action
• The Challenge of Cross-Labeling
• Evidentiary Standards/Authorities
• Parallel Review

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2.) What areas are most important for
guidances3.) How can the Agency best
collaborate

• Guidance Development
• Additional Mechanisms for Efficient Review, and
  Flexible Standards
• Training
• Transparency

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Bottom Line

• Industry looks forward to working with the Agency
  to foster and facilitate innovation of delivery
  systems and other forms of combination technology