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Regulation of Regenerative Medicine Products

Adrian P Gee1

  • 1cGMP Facilities, Center for Cell & Gene Therapy, Baylor College of Medicine, Houston, TX, USA. agee@bcm.edu.

Advances in Experimental Medicine and Biology
|September 22, 2018
PubMed

Keywords:
Cellular therapiesExtracellular matrixFDA guidanceFood and Drug AdministrationGDraft guidanceGMP manufacturingGood manufacturing practicesInvestigational new drug applicationMinimally manipulatedMore than minimally manipulatedRegenerative medicineRegulatory authority

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