Guidance for Industry. Guidance for Human Somatic Cell Therapy and Gene Therapy

摘要

This guidance document updates and replaces the 1991 PTC with new information211u001eintended to provide manufacturers with current information regarding regulatory 211u001econcerns for production, quality control testing, and administration of 211u001erecombinant vectors for gene therapy; and of preclinical testing of both cellular 211u001etherapies and vectors. These guidances are not regulations, but rather represent 211u001eissues that the Center for Biologics Evaluation and Research (CBER) staff 211u001ebelieves should be considered at this time.