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Talking The Cure: Discussing the impact of Covid-19 on cell, tissue, and gene therapy products

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Content provided by Hogan Lovells. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Hogan Lovells or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ro.player.fm/legal.
In this episode, I talk with Michael Druckman, Jane Kalinina and Bert Lao about the the impact of Covid-19 on cell, tissue, and gene therapy products. We touch base on the enforcement discretion for tissue products and those transitioning under explicit enforcement and approval to satisfy good manufacturing practices under the FDA. In addition, we focus on orphan drug sameness and individualized therapies issues. Overall an interesting overview on the cell, tissue, and gene therapy products and its market developments.
  continue reading

52 episoade

Artwork
iconDistribuie
 
Manage episode 291848497 series 2916794
Content provided by Hogan Lovells. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Hogan Lovells or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ro.player.fm/legal.
In this episode, I talk with Michael Druckman, Jane Kalinina and Bert Lao about the the impact of Covid-19 on cell, tissue, and gene therapy products. We touch base on the enforcement discretion for tissue products and those transitioning under explicit enforcement and approval to satisfy good manufacturing practices under the FDA. In addition, we focus on orphan drug sameness and individualized therapies issues. Overall an interesting overview on the cell, tissue, and gene therapy products and its market developments.
  continue reading

52 episoade

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