A guidance providing recommendations for the submission of a biologics license application (BLA) or investigational new drug (IND) application for placental and umbilical cord blood products that are: (1) manipulated minimally; (2) intended for hematopoietic reconstitution in patients with hematological malignancies; and (3) intended to be used in recipients unrelated to the donor, was published by the FDA. Titled “Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies,” the guidance also contains information about the manufacturing of these products referred to as hematopoietic progenitor cells, cord (HPC-C) and regulatory compliance. Manufacturers of peripheral blood or cord hematopoietic stem and progenitor cells other than those described may need to submit investigational new drug applications or other premarketing applications appropriate for those products, as the guidance only applies to HPC-C products.
SOURCE: FDA Notice
For more information on this and related topics, consult the CCHFDA Food, Drug and Cosmetic Law Reporter.
Visit our News Library to read more news stories.
Food, Drug and Cosmetics Law Reporter
Everything you need to know about Food and Drug Regulations.Full-text source covering federal and state laws and regulations and court decisions that govern the safety, effectiveness, purity, packaging and labeling of food, drugs and cosmetics. Learn More » |
Medical Devices ReporterAccess the full text plus expert analysis of all laws and regulations governing the classification, approval, manufacture, and marketing of all medical diagnostic, and radiological devices. Learn More »
|
