- Considerations for tissue-engineered and regenerative medicine product development prior to clinical trials in the United StatesMark 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...
- Regulation of xenogeneic porcine pancreatic isletsJudith 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...