Regenative Labs Sues FDA Over Nearly 3-Year Delay in Export License
Regenative Labs, a Florida-based biotech company specializing in human tissue therapy using umbilical cord cells, has filed a federal lawsuit against the FDA for allegedly unlawfully withholding a Certificate to Foreign Governments (CFG). The company has been waiting nearly three years for the FDA to process its application to sell products overseas, despite being legally registered in the U.S. since 2020. The FDA has refused to act on the application, citing a potential reclassification of the company's products from human cell and tissue products (HCT/Ps) to drugs, which would require additional testing. Regenative Labs argues the delay is arbitrary and has caused material harm, including lost global market opportunities. The lawsuit also aims to bring the issue to the Trump administration, which could resolve regulatory uncertainty created under the Biden administration. The Supreme Court previously declined to review a similar case involving FDA classification of tissue-derived products.
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