FDA Guidance for Industry: Cellular Therapy for Cardiac Disease
Title:
FDA Guidance for Industry: Cellular Therapy for Cardiac Disease
Origin/Publisher:
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/ , http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM164345.pdf
Document Type:
Guidance
Content:
This guidance provides you, sponsors who are developing cellular therapies for the treatment of cardiac disease, with recommendations on the design of preclinical1 and clinical studies, and on the chemistry, manufacturing, and controls (CMC) information to include in an investigational new drug application (IND) for cardiac cellular therapy.