Combination Products

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Combination Products

• NEMAs Comments for the Office of Combination
  Products Public Hearing

Terry Sweeney, Philips Medical Systems
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Question 2

• Safety and Effectiveness should be considered on
  a component basis
• Imaging Contrast Agent
• Imaging Device (Magnetic Resonance, Ultrasound,
  etc.)
• Effectiveness should be delegated to the
  component with the Primary Function
• Imaging system creates the image, Imaging system
  has the primary function.

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Question 2 - cont.

• Center with appropriate expertise in the primary
  function should lead the review of effectiveness
• CDRH should be lead reviewer for effectiveness of
  imaging systems using contrast agents that have
  been approved for safety by CDER.

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Question 3

• Use review process appropriate to the component
• Contrast Agent Drug safety CDER
• New drug
• Revised dosing
• Imaging Device Imaging Efficacy CDRH
• New indication
• Expanded indication

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Question 4

• Use Application appropriate for the component
• Contrast Agent Drug Application processes
• NDA, aNDA
• Imaging Device Device application processes
• 510(k), PMA

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Question 5

• Use Quality System appropriate for the component
• Contrast Agent cGMP
• Imaging Device QSR

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Question 6

• Use adverse event reporting system appropriate
  for the cited component
• Contrast Agent Adverse Experience Reports
• Imaging Device Medical Device Reports (MDR)

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Question 7

• Separate cross labeling requirements
• Use Least Burdensome provisions to set
  appropriate regulatory controls
• Intended Use statements may be distinct based
  upon safety risk
• Contra-indications may be applied to only one OR
  both components
• Cross-reference high-risk issues
• De-couple component-specific issues (i.e.
  effectiveness)

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Question 7 - cont.

• Allow manufacturers of each component of a
  combination product to modify labeling in line
  with a high degree of patient protection
• Pharmacology Agent manufacturer
• Imaging effectiveness Device manufacturer
• Allow Center with expertise in each component to
  review labeling for that component
• Contrast Agent CDER
• Imaging Device CDRH