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.
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| Veröffentlicht in: | The New England journal of medicine 2018-02, Vol.378 (6), p.504-505 |
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| container_end_page | 505 |
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| container_issue | 6 |
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| container_title | The New England journal of medicine |
| container_volume | 378 |
| creator | Charo, R. Alta Sipp, Douglas |
| description | 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. |
| doi_str_mv | 10.1056/NEJMp1715736 |
| format | Article |
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| fulltext | fulltext |
| identifier | ISSN: 0028-4793 |
| ispartof | The New England journal of medicine, 2018-02, Vol.378 (6), p.504-505 |
| issn | 0028-4793 1533-4406 |
| language | eng |
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| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; ProQuest Central UK/Ireland; New England Journal of Medicine |
| subjects | 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 |
| title | Rejuvenating Regenerative Medicine Regulation |
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