Eternity in Medical Information -- Medisurf
Items 1 ~ 8 of 4, Page 1 of 1
Statement from FDA Commissioner, Director of the Center for Biologics Evaluation and Research on new policies to advance development of safe and effective cell and gene therapies
01.15.2019 U.S. FOOD & DRUG ADMINISTRATION
FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice
Genetech, Inc. warned about umbilical cord blood-derived cellular products distributed by Liveyon, LLC. FDA is also sending letters to other firms and providers offering stem cell treatments notifying them of agency’s regenerative medicine policy framework.
12.20.2018 U.S. FOOD & DRUG ADMINISTRATION
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new strategic framework to advance use of real-world evidence to support development of drugs and biologics
12.06.2018 U.S. FOOD & DRUG ADMINISTRATION
FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk
The U.S. Food and Drug Administration has warned StemGenex Biologic Laboratories LLC (StemGenex) of San Diego, Calif; its owner/manager Rita F. Alexander and laboratory and medical director Jenny R. Galloway, M.D. about marketing a purported stem cell product without FDA approval ...
11.13.2018 U.S. FOOD & DRUG ADMINISTRATION
   
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