Federal Register Final rule: FDA is requiring human cell, tissue, and cellular and tissue-based product establishments to follow current good tissue practice, which governs the methods used in, and the facilities and controls used for, the manufacture of the products, recordkeeping, and the establishment of a quality program. The agency is also issuing new regulations on labeling, reporting, inspections, and enforcement that will apply to manufacturers of those products regulated solely under the authority of the Public Health Service Act, and not as drugs, devices, and/or biological products. To view this final rule, click here.
