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Why is islet transplantation 
still not available to the patients with Type 1 Diabetes in the US?!  
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Correspondence with the regulators

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Jan 2022​

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  • Letter to CBER/FDA  

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May/June 2021​

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  • Letter to the President of UNOS (United Network for Organ Sharing)

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  • Letter to HRSA (Health Resources and Human Services), Division of Transplantation

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May 2021​

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  • Letter to Editor

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       Reflection on the FDA review of the Biological License Application for human islets for                    transplantation

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May 2021​

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  • Letter to Xavier Becerra, the Secretary of HHS (Health and Human Services)

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       New evidence based on the BLA review by the FDA and the Advisory Committe voting

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March 2021​

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  • Letter to Xavier Becerra, the Secretary of HHS (Health and Human Services)

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January 2021​

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  • Letter to Xavier Becerra, the Secretary of HHS (Health and Human Services)

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  • Letter to Xavier Becerra, the Secretary of HHS (Health and Human Services)

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Fall  2020​

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  • FDA clarification about waiving exclusive rights to product marketing based on the Orphan Drug Designation

       

       exclusive rights waiver can be submitted after BLA is granted and withdrawn at any time  

  • Letter to Alex Azar, the Secretary of HHS (Health and Human Services)

  • Response from the FDA/CBER  (Center for Biologics Evaluation and Research)

  • Second letter to Alex Azar, the Secretary of HHS (Health and Human Resources)

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Fall 2019 

  • Letter to Norman Sharpless M.D., the Commissioner of the FDA              (October 2019)

  • Response from CBER/FDA    

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Fall 2018 

  •  Letter to CBER/FDA                                                                                           (August 2018)

  • Response from CBER/FDA                                                                          (November 2018)

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