The Expedited Investigational New Drug (IND) Pilot Program – The FDA’s Personal Transfer of Regulatory Obligations?

Schematic courtesy of FDA

The principal benefit is well-reasoned. Within the program’s description, it is noted that during the translational phase a sponsor’s formal mechanisms for Agency discussion are limited to a finite number of interactions such as INTERACT and pre-IND meetings. And while practiced regulatory affairs professionals may advise on additional avenues, both formal and informal, the point remains – the communication is not nearly as dynamic as sponsors would likely prefer. An ability to flexibly present proposals for evaluation and feedback should render the same level of insights as would a formal meeting, but without the PDUFA-mandated lead time.

The pilot program appears to address this deficiency. During what FDA titles the Pre-IND (PIND) phase, the sponsor will be able to provide rolling submission of disciplinary “components” to FDA in order to seek regulatory concurrence. These components will have been advised upon and vetted by the QRI, thereby ostensibly increasing the scientific rigor, and providing a potentially deeper understanding of how best to establish the IMP’s quality and risk-benefit profile (e.g., what nonclinical studies will be necessary? What manufacturing activities and tests are required? How should the proposed clinical trial be designed and conducted?). Theoretically, such well-formulated data packages should ease FDA’s review and allow them to more readily provide response.

Unfortunately, this is where the available guidance tails off and additional granularity is likely needed. In the companion webinar (August 2026), the FDA noted that a PIND component is not akin to an IND module. It was further described that these components will be broken down into clinical, nonclinical and CMC disciplines; however, no further instruction was provided. A conservative estimate could view a component as a series of related IND modules – though there may then be more formality to their authorship, adoption of this viewpoint would lead to more review-accessible and IND-ready deliverables.

Still, this uncertainty means that the biggest theoretical boon, that of the rolling review, remains ill-defined. Importantly, the FDA webinar discussants noted that all opinions provided during this review will be binding, eliminating any hypothetical risk of shifting advice. The FDA also stated that pre-review of materials is not only feasible, but likely, and as such the normal 30-day review timeline should be truncated. However, the text of the pilot press release still notes that the IND review only commences upon submission of the final component, similar to the rolling review standard for applications for licensure. Correspondingly, regulatory professionals may be best served anticipating the longer end of the timeline so as not to artificially delay subsequent milestones.

The dynamic provision of components and receipt of advice would appear to replace the formality of INTERACT and pre-IND meetings. Further, selection to the Pilot Program would likely stand as an effective public-facing deliverable, signifying the sponsor’s progress and FDA standing. However, it should be noted that expectations for documentation (e.g., eCTD modules and formality) are likely to remain, and establishing a relationship with a QRI may cost time and a level of certainty, given the recency of this FDA initiative. Smaller biotech companies may be reticent to accept the Expedited IND approach until it is more firmly vetted, and may continue to opt for the established formal meeting approach. Accordingly, FDA notes the program is voluntary, and that traditional PDUFA meetings are still encouraged.

FDA further notes, perhaps hopefully, that an expedited IND submission should work hand-in-hand with an Institutional Review Board’s (IRB) ethical review, going as far as to note that a draft clinical protocol may be submitted to an IRB during the FDA’s rolling review, and that sponsor-site agreements may also commence during this time. To this point, forward-looking commercial IRBs may even choose to proactively play ball, declaring themselves as “QRI-friendly” bodies ready to receive review materials in line with FDA’s declaration. Here again enthusiasm should be tempered – IRBs remain bound by their own distinct regulation (21 CFR 56) and governance principles. Further, many IRBs still like to receive documentation of FDA’s IND Safe to Proceed notification before commencing their review.

As to the establishment of qualified QRIs, and the associated timeline, a healthy skepticism is warranted. While it’s straightforward enough to believe that subject matter experts across disciplines could coalesce to provide the breadth of FDA-requested inputs, it’s important to remember that the gears of the US government traditionally grind slowly. The rate-limiting assessment, procurement and contractual processes should not be underestimated given the massive scale of this proposed paradigm shift.

In totality, the pilot is promising but aspirational. Regulatory affairs professionals are likely left wondering how the program will translate and evolve, or whether it’s akin to some of the other more nebulous press releases and proposed programs promulgated by the current administration. Ultimately though, until QRIs are established and qualified following the pilot program, the question as to how precisely they catapult a successful IND remains.

For IMP Sponsors seeking to learn more about the Expedited IND Pilot Program, or for any additional US regulatory needs, please feel free to contact Boyds for assistance.