> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Bio Plan to Maintain U.S. Biotechnology Lead
- URL: https://www.fdaweb.com/bio-plan-to-maintain-u-s-biotechnology-lead/
- Published: 2026-11-10T21:58:14.000Z
- Updated: 2026-11-10T21:58:14.000Z
- Author: David McFarland
- Tags: Biologics

BIO says the window to protect America’s biotechnology lead is closing and it offers a seven-step plan to ensure the U.S. remains the global biotech leader for decades to come. In a [white paper](https://www.bio.org/sites/default/files/2026-11/bio-advance%5Ffullpaper%5Fdigital%5F11042026.pdf?ref=fdaweb.com), “Bio Advance: Securing America’s Biotech Century,” the trade association says the biotechnology race “is this generation’s space race. The country that wins will not only shape the future of medicine. It will gain an enduring economic and national security advantage. Success will take an all-of-government effort that unites policymakers, industry, and the research community.”

It calls on the administration and Congress to act on these seven priorities:

- establish a White House Office of Biotechnology;
- accelerate the path to first-in-human clinical trials;
- modernize and streamline development at all stages in the U.S.;
- improve patient access to clinical trials;
- ensure sustained support for academic and government biomedical research;
- enable and incentivize U.S. contract manufacturing capacity and expertise; and
- strengthen intellectual property protections and economic incentives that drive access to capital.

BIO says FDA has a role to play in carrying out several of the priorities:

- implement risk-based requirements for first-in-human trials and improve regulatory engagement and review processes;
- advance alternatives to animal testing;
- reduce unnecessary delays in institutional review board review, contracting, and site activation;
- build a national Phase 1 clinical trial network;
- ensure that regulatory frameworks can accommodate emerging science;
- leverage innovative technologies and approaches to improve trial efficiency; and
- strengthen and expand existing clinical trial networks to support the broader clinical research ecosystem.

"The reforms outlined in this brief are designed to address the central risks to America’s biotech sector,” the report concludes. “Strengthening capital formation would keep investment, talent, and entrepreneurial companies here at home. Modernizing FDA processes and expanding domestic capacity for clinical development and manufacturing would reduce our reliance on foreign competitors for the medicines Americans depend on. Bolstering intellectual property protections would reinforce the foundation of our innovation ecosystem — and help ensure the next great discoveries are developed, owned, and brought to market in the United States.”