A Florida biotech company is asking a federal court to require the U.S. Food and Drug Administration (FDA) to act on long-pending export applications, arguing that delays dating back to the Biden administration have prevented the company from competing internationally and expanding its American operations.
The case also comes as many in the life sciences industry believe the Trump administration has signaled a more responsive approach to reducing regulatory backlogs and supporting domestic manufacturing.
Regenative Labs says it hopes the current administration will bring greater clarity and predictability to the process while allowing innovative American companies to compete globally.
Regenative Labs, a Pensacola-based biotechnology manufacturer, filed a complaint in federal court this week asking the FDA to act on multiple pending applications for Certificates to Foreign Government (CFGs), export documents required by many countries before they will accept certain U.S.-manufactured medical products.
While the dispute centers on export certificates, it also reflects a broader debate in Washington over how regulatory delays can affect American manufacturers, particularly small and mid-sized companies seeking to expand into international markets.
Founded in 2019, Regenative Labs manufactures human birth tissue allografts derived from ethically donated umbilical cord tissue.
The products are processed and rigorously tested under applicable FDA requirements and are designed to provide cushioning and structural support in homologous medical applications.
According to the complaint, the company has sought CFGs for multiple products on three separate occasions since 2023. While the FDA issued a certificate for one product, AmnioText, following the company's September 2025 application, Regenative says eight additional applications have remained unresolved.
Rather than approving or denying those requests within the agency's statutory 20-day timeframe, the applications were placed into a "Return for Action" status.
The company argues that the unresolved applications have effectively prevented it from exporting products to overseas markets, limiting growth opportunities and delaying planned investments in U.S. manufacturing.
"Small businesses like ours deserve a fair, predictable, and timely regulatory process," CEO Tyler Barrett said. "Decisive FDA action on our applications will allow us to serve patients around the world and add jobs in the U.S."
While the FDA is not challenging the safety or quality of Regenative's products, the company is asking the court to require the FDA to make a decision on applications that have remained pending for months.
Regenative has been recognized by the FDA as a registered Human Cell and Tissue Establishment since 2020 and renewed that registration for 2026. Company officials also say they do not expect any disruption for existing domestic customers while the litigation proceeds.
The lawsuit arrives as lawmakers and policymakers continue examining ways to strengthen domestic manufacturing, expand American exports, and reinforce the nation's leadership in biotechnology.
Supporters of those efforts argue that predictable regulatory processes are essential for companies investing in research, manufacturing, and high-skilled jobs.
For Regenative, the outcome could extend well beyond access to foreign markets. Company leaders say obtaining the export certificates would allow the Pensacola-based manufacturer to expand production, invest further in its Florida operations, create hundreds of additional American jobs, and bring U.S.-developed biotechnology products to physicians and patients around the world.
