FDA Draft Guidance for Industry Recommendations for Microbial Vectors used for Gene Therapy
Titel:
FDA Draft Guidance for Industry Recommendations for Microbial Vectors used for Gene Therapy
Internet:
Herkunft/Verlag:
Office of Communication, Outreach and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM466625.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery
Dokumentenart:
Guidelineentwurf
Inhalt:
FDA Empfehlungen für IND Antragsteller für die Nutzung von mikrobiologischen Verktoren in der Gen Therapie in frühen klinischen Phasen.