Drugs

FDA Seeks Alternate Path to Fed Contracting for Tech Access

FDA says it is exploring a new way to contract directly with venture capital–backed innovators in an effort to possibly speed adoption of emerging technologies and reduce reliance on traditional federal contractors. An agency Request for Information (FFI)is seeking input from venture capital firms on a proposed contracting model that would allow the agency to establish direct relationships with qualified investment firms. Under the concept, companies within an approved firm’s portfolio could compete for and receive task orders to support FDA work ranging from research and technology deployment to regulatory innovation, an agency notice says.

FDA commissioner Marty Makary says the agency wants to tap into cutting-edge capabilities that are often developed outside the federal government’s usual vendor base. “We should be harnessing the incredible talent of America’s innovators, instead of relying on middlemen and D.C. insiders,” he says, adding that the approach is intended to enable more direct collaboration with entrepreneurs.

The agency says many breakthrough technologies relevant to its public health mission — including artificial intelligence, biotechnology, medical devices, and regulatory technology — are being built by startups backed by venture capital. But existing contracting mechanisms, FDA notes, tend to favor large systems integrators focused on labor-based services rather than scalable products. Small business set-aside programs can also be difficult for early-stage companies to access and have faced scrutiny over misuse.

Under the proposed framework outlined in the RFI, venture capital firms would be vetted against qualification criteria and compliance requirements. Portfolio companies could then compete for FDA task orders without going through traditional prime contractors. The agency is asking for feedback on issues including financial and administrative structures, intellectual property protections, and regulatory compliance.

Responses to the RFI are due by 2 pm EST on 1/18/2026.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome