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FDA Consultations on CAR T Products and Human Genome Editing

  
FDA Draft Guidances Released March 2022

Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products - Draft Guidance for Industry - LINK
Human Gene Therapy Products Incorporating Human Genome Editing- Draft Guidance for Industry - LINK


ISCT Global Regulatory Committees and the Lab Practices Committee will be responding to these FDA Draft Guidances.  ISCT Members are encouraged to submit their comments to Rosalie Ho, ISCT Regulatory Program Specialist for consideration in the final submission to FDA.

Please submit your comments using the forms below to rosalie@isctglobal.org by May 18, 2022. 

Comment form- Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products - Draft Guidance for Industry
Comment form - Human Gene Therapy Products Incorporating Human Genome Editing- Draft Guidance for Industry

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