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# Support, Suggestions for Expedited IND Pilot
- URL: https://www.fdaweb.com/support-suggestions-for-expedited-ind-pilot/
- Published: 2026-08-27T12:00:00.000Z
- Updated: 2026-09-14T12:05:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161698

The Biotechnology Innovation Organization (BIO) says it agrees with FDA that it is critical to shorten the time it takes from drug identification to first-in-human study. In a comment letter, BIO [says](https://www.regulations.gov/comment/FDA-2026-N-4699-0150?ref=fdaweb.com) the agency’s proposed pilot for an expedited Investigational New Drug (IND) “presents a timely opportunity to test approaches that could meaningfully reduce delays and improve predictability in early-stage clinical development while preserving safety, scientific rigor, and regulatory oversight.”

If FDA proceeds with the pilot as envisioned, BIO recommends that it consider following these core principles:

- pursue a phased approach to establish processes, evaluate outcomes, and identify implementation challenges before expanding to more complex modalities and patient populations;
- preserve FDA authority and clarify the Qualified Research Institution (QRI) role;
- streamline pre-IND engagement and predictability;
- avoid creating new bottlenecks outside FDA review;
- define success using balanced end-to-end metrics;
- ensure meaningful net efficiency and FDA capacity;
- consider scalability and broader applicability; and
- consider how fees, capacity, and eligibility criteria may affect equitable access and ensure that the standard IND pathway remains viable and appropriately supported.

In its [response](https://www.regulations.gov/comment/FDA-2026-N-4699-0185?ref=fdaweb.com), Pfizer lists comments and recommendations about specific opportunities for reform:

**opportunities to modernize the IND process**

- streamline IND documentation;
- modernize investigator listing requirements;
- reduce the burden of duplicative IND reporting;
- leverage new approach methodologies;
- ensure meaningful opportunities for FDA-sponsor consultation;
- reform clinical hold practices;
- address digital and artificial intelligence modernization of IND preparation and review;
- transition towards a risk-based IND safety reporting framework; and
- drive best practices through training and education,

**criteria for the expedited IND pilot program**

- establish clear criteria for QRIs;
- preserve FDA decision-making authority and scientific dialog;
- promote QRI alignment with Institutional Review Board review;
- maximize the utility of rolling IND submissions; and
- establish robust outcome metrics.

Friends of Cancer Research [says](https://www.regulations.gov/comment/FDA-2026-N-4699-0163?ref=fdaweb.com) the proposed pilot “provides an important opportunity to test whether new approaches can meaningfully reduce the time and complexity associated with initiating first-in-human studies.” It gives its perspectives on QRIs, rolling IND review, process efficiency, and measuring pilot success.

Parexel [recommends](https://www.regulations.gov/comment/FDA-2026-N-4699-0183?ref=fdaweb.com) that under the pilot, FDA should establish a high-capability QRI network, implement a predictable rolling IND review process, test the pilot across the full range of products and IND complexities, manage potential conflicts of interest through targeted safeguards, and use the pilot as a catalyst to modernize both IND review processes and preclinical/chemistry, manufacturing, and controls expectations that affect the time to first-in-human studies.

Finally, Pharmaceutical Research and Manufacturers of America (PhRMA) [says](https://www.regulations.gov/comment/FDA-2026-N-4699-0191?ref=fdaweb.com) it strongly supports FDA efforts to accelerate the initiation of Phase 1 first-in-human trials in the U.S. It says it is unclear how the proposed use of QRIs will accelerate the start of first-in-human trials. PhRMA offers specific recommendations for:

- designing and implementing an effective and useful pilot program;
- risks, oversight, and evaluation; and
- additional considerations.