The Hill | David Mansdoerfer
August 20, 2026
The Hill examined the ongoing race for biotechnology leadership and highlighted Regenative Labs as a
case study in how regulatory delay can make it harder for America to hold its position in the field.
With China rapidly expanding its own biotechnology sector, the author argues that the United States
needs a regulatory environment that allows domestic innovators to compete worldwide. Regenative Labs
has spent three years waiting for the FDA to act on its applications for a Certificate to Foreign
Government, the document required to sell its products in foreign markets, despite federal law
directing the agency to act within 20 days.
The article makes the case that this delay has left Regenative at a competitive disadvantage,
preventing the company from expanding internationally and from growing its workforce in Florida
while foreign competitors continue to operate in those markets.
“An American company with American-developed technology has been put at a competitive
disadvantage…”David Mansdoerfer, The Hill
The piece places Regenative’s experience in the broader context of America’s competition with China,
arguing that regulatory inaction carries consequences beyond a single company by limiting domestic
manufacturing, investment, and the development of new medical technologies. Every delayed decision,
the author writes, is a missed opportunity for American workers and for the homegrown companies
building the next generation of medical innovation.
This coverage underscores the broader importance of ensuring that regulators provide timely answers
and allow American innovators to compete with other countries on a level playing field.