Not just the FDA, but the EMA in Europe as well. "Non homologous use" or "substantial manipulation" makes it an ATMP (advanced-therapy medicinal product): http:

Not just the FDA, but the EMA in Europe as well. "Non homologous use" or "substantial manipulation" makes it an ATMP (advanced-therapy medicinal product): http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/06/WC500187744.pdf http://www.ema.europa.eu/docs/en_GB/document_library/Scienti...