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Shaobo Ding, [email protected] These authors have contributed equally to this work This article was submitted to Experimental Pharmacology and Drug Discovery, a section of the journal Frontiers in Pharmacology Disclaimer All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers

Safety, Product Integrity, and the Problem of Unregulated Supply The primary clinical concern is not simply uncertainty regarding biologic effects, but uncertainty regarding product composition, sterility, and manufacturing quality