By Patrick Cooney, for AMRC
Illustrative image generated using AI
FEDERAL AGENCY NEWS
FDA Announces New Drug Pilot
On September 15, 2026, the U.S. Food and Drug Administration announced the final design of the Expedited Investigational New Drug (IND) Pilot with the goal of accelerating clinical trial timelines and eliminating regulatory hurdles to maintain American leadership in global medical innovation. Driven by the President’s directive, the pilot seeks to accelerate the time it takes from identifying a drug to initiating a first-in-human clinical trial by partnering drug companies with qualified research institutions (QRI). The FDA will accept applications to participate in the pilot until October 30, 2026.
According the the agency press announcement, the QRIs selected for the pilot will bring specialized and substantial scientific expertise to the IND application preparation process allowing the FDA to review and accept individual components on a rolling review during the pre-IND phase, rather than waiting for all components to begin review. The pilot will help test whether this allows issues with an IND application to be identified and resolved in real time sooner — thereby reducing the risk of the FDA placing the first-in-human clinical trial protocol on hold during the 30-day IND, and making the path from scientific discovery to first-in-human trial faster, more predictable, and more collaborative.
The FDA’s Expedited IND Pilot webpage provides detailed information on program eligibility criteria, conflict of interest requirements, and the selection criteria the agency will use to determine participation. Drug sponsors and prospective QRIs will apply as a pair with drug sponsors submitting applications to the FDA.
The application period will be open until October 30, 2026. Applications will undergo review by FDA scientific experts. FDA expects that 8–10 Sponsor-QRI pairs will be selected to participate in the initial pilot.
Senate Hearing on FDA Commissioner Nominee
On September 17, 2026, the Senate HELP Committee announced it will hold Dr. Heidi Overton’s FDA Commissioner confirmation hearing on Thursday, September 24th. Reports indicate she intends to be more collaborative with FDA career staff than her predecessor if confirmed. The hearing comes as FDA faces pressure to rebuild confidence among industry and public-health groups following sustained turnover in agency leadership. AMRC members should watch for questions on clinical trial reform and vaccine policy, which are expected flashpoints.
DoD Announces CDMRP Funding
On September 20, 2026, the Department of Defense’s Congressionally Directed Medical Research Programs (CDMRP) announced $1.27 billion across 34 research programs for FY2026. AMRC members with disease-specific interests should review the newly announced program list.
CAPITOL HILL NEWS
Congress In Focus
As of Friday, September 18, 2026, the House and Senate are now on different tracks heading into the midterms. The biggest change is that House leadership has effectively shut down regular legislative business until after Election Day, while the Senate still has a short September work period remaining. The Congress will reconvene after the November elections to address funding issues and other remaining business.
The most important longer-term issue for the clinical research community is the reauthorization of the Prescription Drug User Fee Act (PDUFA). The current PDUFA VII authorization expires in September 2027, meaning Congress will need to enact new legislation to allow FDA to continue collecting prescription drug user fees supporting the drug-review process. That process took an important step forward on September 16, when FDA held a public meeting on the proposed PDUFA VIII recommendations covering fiscal years 2028 through 2032.
The emerging PDUFA VIII framework is particularly relevant to AMRC because FDA’s discussions have included several initiatives directly affecting clinical development. Among the issues considered during the negotiations are real-world evidence, model-informed drug development, complex and innovative trial designs, rare-disease endpoints, regulatory science, FDA-sponsor interactions, and ways to facilitate first-cycle reviews.
The completion of the FDA-industry negotiations does not end the process. Attention will increasingly shift to Congress, where the House Energy and Commerce Committee and Senate Health Education Labor Pensions Committee (HELP) will have significant roles in crafting the legislative reauthorization.
That transition creates an important opportunity for the clinical research community. PDUFA legislation historically becomes a vehicle for broader FDA policy provisions, and lawmakers are already examining ways to make U.S. clinical development faster and more competitive.
For AMRC, the central question should be how Congress can build upon FDA’s regulatory modernization efforts while ensuring that reforms address the operational realities of conducting trials at scale. Site participation, patient recruitment, decentralized and technology-enabled research, real-world data, investigator capacity, and unnecessary administrative burdens should all be part of that conversation.
