This post was written by Paul Sheives.
FDA recently released two guidance documents (one in draft form) concerning hematopoietic reconstitution for specified indications as hematopoietic progenitor cells, cord (HPC-C), which provide information to manufacturers seeking licensure and potential sponsors for Investigational New Drugs Applications (INDs). FDA announced that it no longer intends to exercise enforcement discretion regarding IND and Biologics License Application (BLA) requirements for these products. The final guidance document is entitled “Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications,” and the draft guidance is entitled “Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications.” Other recent FDA guidance documents include the following:
- Labeling for Human Prescription Drug and Biological Products–Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information.
- Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.
- Guidance for Industry on Investigator Responsibilities: Protecting the Rights, Safety, and Welfare of Study Subjects.