Current state of U.S. Food and Drug Administration regulation for cellular and gene therapy products: potential cures on the horizon

Author:

Mendicino Michael,Fan Yong,Griffin Deborah,Gunter Kurt C.,Nichols Karen

Publisher

Elsevier BV

Subject

Cancer Research,Transplantation,Cell Biology,Genetics(clinical),Oncology,Immunology,Immunology and Allergy

Reference153 articles.

1. Alliance for Regenerative Medicine. 2018 Annual Report, https://alliancerm.org/publication/2018-annual-report/. [accessed 09 April 2019].

2. Alliance for Regenerative Medicine. Publications and Presentations. 2019. https://alliancerm.org/publications-presentations/. [accessed 09 April 2019].

3. Kymriah, https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm573706.htm; 7 May 2018 [accessed 22 October 2018].

4. Yescarta, https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm581222.htm; 20 February 2018 [accessed 22 October 2018].

5. Luxturna, https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm589507.htm; 26 July 2018 [accessed 22 October 2018].

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