Understanding US FDA Regulatory Responsibilities for Cell Therapy Companies

9 September 2021
What cell therapy companies need to know about working with the FDA during a product development program.

Are you a cell therapy company developing a novel cell therapy product for the US market? Do you have a regulatory approval plan and understand the roadblocks that you may face at the US FDA?

No matter where you are in your cell therapy product development program, it is critical that you have a strategic regulatory plan and that you understand your obligations for FDA approval.

Join Buchanan Ingersoll & Rooney attorneys Dr. Barbara Binzak Blumenfeld, Esq. and Tina Hu-Rodgers, Esq. as they discuss the importance of planning ahead, understanding the FDA approval requirements, and avoiding regulatory pitfalls during the cell product development journey.


This 60 minute webinar will feature a combination of presentation and Q&A between the Buchanan experts, as well as answering audience questions in real time as they arise. Key topics will include:

  • The importance of a US FDA regulatory plan to chart your company’s path forward.
  • An overview of the US FDA cell therapy product requirements.
  • Understanding and planning to avoid the common regulatory pitfalls on the road to approval.
Barbara Binzak Blumenfeld, Ph.D., M.A., Esq.
Buchanan Ingersoll & Rooney PC
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Tina Hu-Rodgers, Esq.
Buchanan Ingersoll & Rooney PC
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This webinar has been brought to you in partnership with Buchanan Ingersoll & Rooney PC.

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