Mark H Lee

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. doi request reprint Considerations for tissue-engineered and regenerative medicine product development prior to clinical trials in the United States
    Mark H Lee
    Center for Biologics Evaluation and Research, U S Food and Drug Administration, Rockville, Maryland 20852, USA
    Tissue Eng Part B Rev 16:41-54. 2010
  2. doi request reprint Regulation of xenogeneic porcine pancreatic islets
    Judith A Arcidiacono
    FDA, Center for Biologics Evaluation and Research CBER, Office of Cellular, Tissue and Gene Therapies, Rockville, MD 20852, USA
    Xenotransplantation 17:329-37. 2010

Collaborators

Detail Information

Publications2

  1. doi request reprint Considerations for tissue-engineered and regenerative medicine product development prior to clinical trials in the United States
    Mark H Lee
    Center for Biologics Evaluation and Research, U S Food and Drug Administration, Rockville, Maryland 20852, USA
    Tissue Eng Part B Rev 16:41-54. 2010
    ..Also described are ways through which product developers can informally and formally interact with the FDA early in the development process to help in the efficient progression of products toward clinical trials...
  2. doi request reprint Regulation of xenogeneic porcine pancreatic islets
    Judith A Arcidiacono
    FDA, Center for Biologics Evaluation and Research CBER, Office of Cellular, Tissue and Gene Therapies, Rockville, MD 20852, USA
    Xenotransplantation 17:329-37. 2010
    ..This article provides an overview of the existing FDA regulatory framework that would be applied to the regulation of clinical trials utilizing xenogeneic porcine pancreatic islets to treat T1D...