Rejuvenating Regenerative Medicine Regulation

By clarifying its position on the handling and therapeutic use of human cell–based products, the FDA has signaled its intention to regulate a broad swath of highly manipulated cellular materials as biologic drugs. This move is welcome, but more remains to be done.

Gespeichert in:

Bibliographische Detailangaben
Veröffentlicht in:	The New England journal of medicine 2018-02, Vol.378 (6), p.504-505
Hauptverfasser:	Charo, R. Alta, Sipp, Douglas
Format:	Artikel
Sprache:	eng
Schlagworte:	Bone marrow Cell- and Tissue-Based Therapy Clinical trials Consumer Product Safety - legislation & jurisprudence Drug Approval Drugs FDA approval Government Regulation Humans Informed Consent Marketing Marketing of Health Services Medical research Medicine Patient safety Regenerative medicine Regenerative Medicine - legislation & jurisprudence State Government Stem Cell Transplantation - legislation & jurisprudence Stem cells Transplantation, Autologous - legislation & jurisprudence United States United States Food and Drug Administration
Online-Zugang:	Volltext
Tags:	Tag hinzufügen Keine Tags, Fügen Sie den ersten Tag hinzu!

Beschreibung
Zusammenfassung:	By clarifying its position on the handling and therapeutic use of human cell–based products, the FDA has signaled its intention to regulate a broad swath of highly manipulated cellular materials as biologic drugs. This move is welcome, but more remains to be done.
ISSN:	0028-4793 1533-4406
DOI:	10.1056/NEJMp1715736