> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Pilot Program for Novel Drug Development Tools
- URL: https://www.fdaweb.com/pilot-program-for-novel-drug-development-tools/
- Published: 2020-11-30T12:00:00.000Z
- Updated: 2026-09-14T16:38:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148183

FDA has launched the Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program for novel drug development tool (DDT) developers. “ISTAND encourages development of DDTs that fall outside of the existing DDT qualification programs: biomarkers, clinical outcome assessments, and animal models for use under the Animal Rule,” an [FDA notice](https://www.fda.gov/drugs/drug-development-tool-ddt-qualification-programs/innovative-science-and-technology-approaches-new-drugs-istand-pilot-program?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. The program’s goal is to provide scientific and logistical support to DDT developers and to FDA’s clinical divisions for incorporating novel technologies and scientific approaches in drug development and regulatory review to accelerate new therapeutics to patients, the notice says. The pilot creates a pathway for developers to submit proposals for novel approaches that do not have an existing regulatory path.

During the pilot phase, FDA anticipates accepting 2-4 applications into the ISTAND program each year through a triage and selection process focusing on impact to public health and possibility of implementation. FDA says that key benefits of the ISTAND program include:

- Access to early FDA feedback for those exploring first time use under the DDT pathway;
- Potential for qualification under the [DDT Qualification process](https://u7061146.ct.sendgrid.net/ls/click?upn=4tNED-2FM8iDZJQyQ53jATUURzbOiTj4rjf8eQ-2FYEfOQ5THSul0bFGo4FhyR4b-2BPkN6tXfIb03jEQfD9nEWL3f9zp6qTLQ1TnQtywumfiKIWTfsqz1eo-2FJuT92HVTN-2FERDegvk6o8O-2BRg0ev6CJDN6sqUPjpwgJqqskgkR3ylXLf82kELPoG9H1avk-2BxY1DHn3KLamcIWdoZeta3y9JSHb-2FtHAdBp7U-2FRPslLnjtNZIyp5qiCe03n28GPEECJQkK-2FxPWwUh4n23vtXezH-2ByXeA-2FGgSgy-2FujfaAGtLdnuIw6SBBkwdc9N3Bhv4jeqWUETd4jCmFU-2B4gNXKDjwjDQXhvhIIGG-2BQk-2BPhgKv5hNEJ7Khk9iT1t7iaP3P1yDZznMRWBsQYq4W0Re0yDkwX-2BKOLe1o0Zv4Ei41Sy0E5-2BpsyrfuMV3nfLoWPdMmldhvEQx-2BY4Txc7qAiYc2c0JcGRJ3ASPAaY0g0Q5RGqaddtCCAhLMLR5NmgeG6WzYl0AsAZE6mi7EMi-2BIoTqRuVopeDCArdN-2FkIsqNM4XjShcOI8jG2z-2FNYdfDtVMcTYd9KztnE-2BZjSrK25tWK4nrLFZBYV6IeO-2FK9EutTmFt-2FHM4gpErsAw32zfMyi3WOCoNTmtJgWz3zRJ-2FNqUyOZBhIrRO-2F5CA-2BZFQ-3D-3DO2qh%5Ff0D7hj0BJ4b-2F7NuVqzPDs7FGiq8VLIwAX0sPSotqoLIZH-2BlHUpIN1Fpx16wXLzBItZQB-2B865N-2BRM-2FfR3UV9b-2B3x5yDeI-2BTg-2FGBCQMWf44N-2FVW9zuahQ2WC9kwjjBJxnVasQFUnesfYwWpXzLU1j08i7H-2Bf8UvM9VsCg36OeF2hfzWhUFy8d1dhd7mGeyCMwOcEUo3I9O7vpsMqV-2F-2BHCIOuJ-2FgyzZ9qiDdfSqqrRMfuyZUcROKEBeZZ6z9K5D9BDUpyN1KysCZYp2qFIPrcSHPIAlx6ExcKm-2Fzj1UiFX9UWJ1YRvMLVemk13NVDgX-2FfHdx1KZmZsJs6M3wU2knYieUg-3D-3D&ref=fdaweb.com), with the flexibility to offer other outcomes if qualification is not the best path; and
- New platforms to efficiently collaborate and share knowledge of new tools across FDA divisions and with external stakeholders including international regulatory bodies, creating more consensus and consistent views from the agency.

Visit the [ISTAND Web page](https://u7061146.ct.sendgrid.net/ls/click?upn=4tNED-2FM8iDZJQyQ53jATUURzbOiTj4rjf8eQ-2FYEfOQ5THSul0bFGo4FhyR4b-2BPkN6tXfIb03jEQfD9nEWL3f97KHcaOOQ7u-2FaCjWJGOMNseOmO8gEl6SYs-2FDXcI1vvll98MimjFL8CeBXKlTveebYHU3ufmS6atjXDwIIroZjnSe87r8sTD7yFIAAeRfTqfRQIdFY3sU-2FhDI-2BmhUXACY1RsxMLjPh5iv6lkCTcAP8-2FoaLkWEPUvjLytkPBHjU-2BXFaDrsPgt0i-2BhZLInneEza12e-2FttvRBe926vcBrEn5vfG6-2F0XA-2B8ZS8Vpz5dLteL-2FL5aokQrQ5Fzjoo-2FY6v32h-2FYyrfRMKdudgKcLfV1rrUfXm-2BJZ1j-2BRCPn7CUL22Rr73JGkt7fiIQa9j-2FXjhTKBYK19BElYFlXW6Caj0Mtuwq6lnAFLM-2BJZQwc60XNCwsll79Gu1rDfYSF85BMIKCnMJs-2FOzq0MQG9TGyZHuh-2BwoltBNC1BSgZrTDYA25xyG-2B5mjGiy65AYdNsW51P6PF-2BMCSjTx7J5z7CiR3AR9-2FBGeeIdh8npQU4nOmagGO0Roy4dvvIdhSgavRh-2BZlmgur8JPYZ8KRBAPCXrD2wV41UQlGpM-2Bqyd52pt3mOuHipR-2FaiMYqHNc5XkP-2FjB9qukRaSc-2FMA-3D-3DldJ7%5Ff0D7hj0BJ4b-2F7NuVqzPDs7FGiq8VLIwAX0sPSotqoLIZH-2BlHUpIN1Fpx16wXLzBItZQB-2B865N-2BRM-2FfR3UV9b-2B3x5yDeI-2BTg-2FGBCQMWf44N-2FVW9zuahQ2WC9kwjjBJxnVasQFUnesfYwWpXzLU1j08i7H-2Bf8UvM9VsCg36OeF2hfzWhUFy8d1dhd7mGeyCMwOg7-2FNV7u1sVhRSZW2TgLqsv8xRGnmzPH2FGF7F31krq0pTaQnQu8cRmcr48-2FQ1CyDsW4HYm4ulVccqS5D9FyThG58INte6BIi2vZgNV57ABRghNT5ix9-2BKL7IBx8FYPhhSxivXOK9R6cRFwmjiZpgMg-3D-3D&ref=fdaweb.com) for more information on the pilot, including examples of concepts that may be considered.