MCRA RESOURCE CENTER
REGULATORY Biologics will one day lead the orthopedic market place and be a part of every device and every patient’s lives. You can view the basic gene and cell therapy guidance documents that are the backbone of the FDA review policy.
BIOLOGICS
• Guidance for Industry - Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans
• Guidance for Industry Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage • Guidance for Industry Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) • Guidance for FDA Review Staff and Sponsors Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) • Guidance for Reviewers Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs) • Guidance for Industry Guidance for Human Somatic Cell Therapy and Gene Therapy • Draft Guidance for Industry - Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage
