FDA Guidance for Industry Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products
Titel:
FDA Guidance for Industry
Considerations for the Design of Early-Phase Clinical Trials of
Cellular and Gene Therapy Products
Internet:
https://www.gmp-navigator.com/files/guidemgr/Design Clinical Trials of Ceelular and gene Therapy.pdf
Herkunft/Verlag:
Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ , https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM564952.pdf
Dokumentenart:
Guidance for Industry
Inhalt:
guidance to assist sponsors of Investigational New Drug Applications (INDs) for cellular therapy (CT) and gene therapy (GT) products.