Regenative Labs Sues FDA Over Three-Year Delay in Export Certificate

Florida-based biotech company Regenative Labs has filed a federal lawsuit against the FDA, alleging the agency unlawfully withheld a Certificate to Foreign Governments (CFG) for nearly three years. The certificate is essential for exporting its human tissue therapy products, derived from donated umbilical cords, to overseas markets. The FDA has refused to process the application, citing a potential reclassification of the company's products from human cell and tissue products (HCT/Ps) to drugs—a change that would require additional testing. However, the FDA has not officially changed its policy, leaving Regenative in regulatory limbo. The company argues the delay has caused material harm and fallen behind global competitors. The lawsuit also presents an opportunity for the Trump administration to resolve the issue, which originated under the Biden administration. The article notes that the Supreme Court recently declined to hear a similar case involving tissue product classification.