BIO Submits Comments on FDA Draft Guidance on Expedited Programs for Regenerative Medicine Therapies for Serious Conditions
February 15, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Expedited Programs for Regenerative Medicine Therapies for Serious Conditions.
This draft guidance provides important information on the expedited programs available to sponsors of regenerative medicine therapies for serious conditions. BIO recommends the FDA provide further guidance to sponsors on which designation (RMAT or Breakthrough Therapy) is most appropriate for different types of programs, along with other comments on how to clarify the guidance.
Download Full Comments Below
BIO Letter Expedited Programs For Regenerative Medicine Therapies Draft Guidance FINAL 2-15-18
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BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Expedited Programs for Regenerative Medicine Therapies for Serious Conditions.
This draft guidance provides important information on the expedited programs available to sponsors of regenerative medicine therapies for serious conditions. BIO recommends the FDA provide further guidance to sponsors on which designation (RMAT or Breakthrough Therapy) is most appropriate for different types of programs, along with other comments on how to clarify the guidance.