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The FDA Courts Sand Hill Road

Is this when the VC-Prime era begins?

Brendan Keeler's avatar
Brendan Keeler
Jan 02, 2026
∙ Paid

The FDA has issued a Request for Information seeking input from venture capital firms on a new contracting model designed to bypass traditional systems integrators and create direct pathways for early-stage, VC-backed innovators to deliver scalable technologies to the agency, particularly in areas like AI, biotech, medical devices, and regulatory technology.

The proposal would allow qualified VC firms to sponsor their portfolio companies to compete for FDA task orders, aiming to fix long-standing barriers in federal procurement that favor labor-heavy middlemen and are difficult for startups to navigate, while also establishing new frameworks for IP protection, compliance, and financial administration.

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