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Guide on CMC Info for Gene Therapy Products
07/12/2018
 

Federal Register notice: FDA has made available a draft guidance entitled “Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs).” The document provides sponsors of a human gene therapy IND with recommendations about CMC information required to assure product safety, identity, quality, purity, and strength (including potency) of the investigational product. To view the notice, click here.


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