The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
FDA Guidance for Industry Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
Origin/Publisher:
FDA/CBER Office of Communication, Outreach 25 and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM610795.pdf
Document Type:
Final Guideline
Content:
The purpose of this draft guidance is to inform sponsors how to provide sufficient CMC information required to assure product safety, identity, quality, purity, and
strength (including potency) of the investigational product (21 CFR 312.23(a)(7)(i)). This guidance applies to human gene therapy products and to combination products1 that contain a
human gene therapy in combination with a drug or device.
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