Draft Guidance for Industry
In this guidance, we, FDA, are providing recommendations to sponsors developing human gene16
therapy0F
1 products incorporating genome editing (GE) of human somatic cells. Specifically, this17
guidance provides recommendations regarding information that should be provided in an18
Investigational New Drug (IND) application in order to assess the safety and quality of the19
investigational GE product, as required in Title 21 of the Code of Federal Regulations 312.2320
(21 CFR 312.23). This includes information on product design, product manufacturing, product21
testing, preclinical safety assessment, and clinical trial design.22
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The contents of this document do not have the force and effect of law and are not meant to bind24
the public in any way, unless specifically incorporated into a contract. This document is25
intended only to provide clarity to the public regarding existing requirements under the law.26
FDA guidance documents, including this guidance, should be viewed only as recommendations,27
unless specific regulatory or statutory requirements are cited. The use of the word should in28
FDA guidances means that something is suggested or recommended, but not required.
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