What are the regulatory requirements for TB diagnostics, both in-country and globally?


  1. What is required for the registration of new diagnostics in the major, high TB burden countries?
  2. Will multiple regulatory approvals be necessary? What will it cost? Is there a pathway to get simultaneous approvals from multiple regulatory agencies?
  3. How critical is FDA approval for global markets and what will it take to get FDA approval?
  4. What are the advantages and disadvantages of getting CE mark versus WHO prequalification versus FDA approval and which of these is needed for major markets?
  5. How strong is the intellectual property in the TB diagnostics area, and specifically within major, target countries?


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