What's New at CBER Update

full-text:

Important Information about IND Requirements for Use of Fecal Microbiota to Treat Clostridium difficile Infection Not Responsive to Standard Therapies
Posted: 6/17/2013
Draft Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System (PDF - 328KB)
Posted: 6/17/2013
Draft Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System (PDF - 133KB)
Posted: 6/17/2013