Insight

Aug 13, 2025, 15:14

New FDA PreCheck Program to Boost U.S. Drug Manufacturing

Jennifer Buell, President and Chief Executive Officer at MiNK Therapeutics, shared a post by FDA on LinkedIn, adding:

“The FDA launched FDA PreCheck, a program to increase regulatory predictability and speed the build-out of U.S. manufacturing sites – part of Executive Order 14293 to promote domestic production of critical medicines.

At MiNK Therapeutics, we are excited about this – as we’ve built an FDA-cleared, in-house U.S. manufacturing – a fully closed, automated, scalable platform capable of producing thousands of doses annually of MiNK Therapeutics off-the-shelf allogeneic iNKT cell therapies.

This infrastructure is key to:

– Ensuring supply security for patients
– Scaling rapidly to meet demand
– Integrating next-gen manufacturing tech efficiently

We are excited to see U.S. manufacturing policy align with our mission – delivering innovative therapies faster while strengthening America’s pharmaceutical supply chain. MiNK Therapeutics is well-positioned to take full advantage of FDA PreCheck’s benefits – bringing lifesaving therapies to patients faster while supporting the United States’ goal of a robust and reliable pharmaceutical supply chain.”

Quoting FDA‘s post:

“Today the FDA announced FDA PreCheck, a new program to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of manufacturing sites in the United States.

FDA PreCheck was developed in response to Executive Order 14293, “Regulatory Relief to Promote Domestic Production of Critical Medicines,” which directs FDA to streamline pharmaceutical manufacturing regulation and eliminate unnecessary requirements while maximizing review timeliness and predictability.”

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New FDA PreCheck Program to Boost U.S. Drug Manufacturing