FDA

This Biotech Company Has Spent Nearly 3 Years in FDA Limbo

The FDA says it can't license Regenative Lab's overseas sales today because it might change its regulations tomorrow. Now, the company is suing.

Eric Boehm | 7.17.2026 2:25 PM

Share on FacebookShare on XShare on RedditShare by emailPrint friendly versionCopy page URL Add Reason to Google

Media Contact & Reprint Requests

(Federal Drug Administration/Midjourney)

An American biotech company that specializes in human tissue therapy* has been waiting for nearly three years for the Food and Drug Administration to process an application to sell products overseas.

Now, it is asking a federal court to get involved—and giving the Trump administration a chance to fix a mess made by its predecessor.

Regenative Labs sued the FDA in federal district court on Thursday, alleging that the agency has "unlawfully withheld" a license the FDA awards to signal to foreign governments that products meet U.S. regulatory standards—a crucial step in being able to sell American-made medical tech in other countries.

There is no question that Florida-based Regenative Labs' products meet U.S. standards, as the company has been lawfully operating in the American market and registered with the FDA since 2020. Regenative........

© Reason.com