Regenative Labs Sues FDA Over Delayed Export License for Stem Cell Therapies
Regenative Labs, a Florida-based biotech company specializing in stem cell therapies derived from umbilical cords, has sued the FDA in federal court for unlawfully withholding a Certificate to Foreign Governments (CFG). The company has been waiting over 10 months for the FDA to process its application, which is required to sell its products overseas. The FDA has cited a 2023 warning letter suggesting the products might need to be reclassified as drugs rather than human cell and tissue products (HCT/Ps), but has not made a final decision. Regenative argues the delay is arbitrary and has caused material harm, including lost global market opportunities. The lawsuit also presents an opportunity for the Trump administration to resolve the regulatory uncertainty left by the Biden administration. The core legal question is whether the FDA can block overseas sales based on a potential future regulatory change.
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