Cellular & Gene Therapy Products
The Center for Biologics Evaluation and Research (CBER) regulates human gene therapy products – products that introduce genetic material into the body to replace faulty or missing genetic material, thus treating or curing a disease or abnormal medical condition. CBER uses both the Public Health Service Act and the Federal Food Drug and Cosmetic Act as enabling statutes for oversight.
The amount of gene-related research and development occurring in the United States continues to grow at a fast rate and FDA is actively involved in overseeing this activity. FDA has received many requests from medical researchers and manufacturers to study gene therapy and to develop gene therapy products.
C. Humphrey & Associates, P.A. assists clients with compliance with the regulation of human cellular and tissue-based products (HCT/Ps). These products are regulated by the Food and Drug Administration as traditional biological products, drugs, devices, or solely under the HCT/Ps regulatory structure of 21 C.F.R. § 1271. Our firm has experience in navigating the intricacies of the FDA regulatory structure for HCT/Ps. We also help clients comply with the American Association of Blood Banks Standards for Cellular Therapies and corresponding state laws.
Our FDA Attorneys and FDA consultants determine which regulations apply to their HCT/Ps, premarket reviews, establishment registration and listing of the HCT/Ps on the FDA website, preparation for establishment inspections, and the import and export of HCT/Ps. We have experience reviewing and compiling standard operating procedures for clients to ensure compliance with FDA regulations for donor screening and testing, Good Tissue Practices, labeling and tracking of HCT/Ps, record keeping, and adverse event reporting requirements. We also help clients with the promotion and advertising of their HCT/Ps and HCT/P services to ensure proper classification under the regulations.