The FDA Now Requires Every Lab-Grown Human Liver to File Form 22C Before Implantation: A Researcher's Guide to Bureaucratic Organogenesis
SAN FRANCISCO — In a stunning development that will surprise no one who has navigated the regulatory landscape of biotechnology, the U.S. Food and Drug Administration has issued new guidelines requiring all lab-grown human organs to complete a 63-page “Organogenesis Readiness Package” before clinical implantation. This includes a carbon footprint report for the organoid, proof of “ethical consent” from the cell line’s originator, and a notarized affidavit stating the researcher hasn’t used any “forbidden growth factors.”