# 2026-12619: FDA Shares New Computer Model Tips for Human Drug Trials

2026-12619, Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials; Draft Guidance for Industry; Availability, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2026-06-24, effective Submit either electronic or written comments on the draft guidance by July 24, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. (as of 2026-07-01).

- Canonical: https://policyrisk.com/federal-register/2026-12619
- As of: 2026-07-01
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-12619
- Title: Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials; Draft Guidance for Industry; Availability
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 38004
- Published: 2026-06-24
- Effective: Submit either electronic or written comments on the draft guidance by July 24, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
- Comments close: 2026-07-24
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-07-01

## In one line

FDA Shares New Computer Model Tips for Human Drug Trials

## Summary

The FDA just dropped a draft guide to help drug makers pick safer starting doses for first-time human drug trials using smart computer models called QSP. This is a big deal for companies working on powerful new drugs that can cause strong reactions, like immune system activations. Comments on this draft are open until July 24, 2026, so get your thoughts in to help shape safer, smarter drug testing!

## Abstract

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials." The guidance is intended to provide recommendations in the application of quantitative systems pharmacology (QSP) modeling when a minimum anticipated biological effect level (MABEL) in first-in- human (FIH), phase 1 trials for drugs and biological products is recommended. This guidance focuses on drugs and biological products for which the MABEL approach can be used to guide starting doses for FIH trials. This includes, but is not limited to, drugs and biological products that may cause cytokine release, T-cell activation, or other potent pharmacological reactions.

## Effects PRIA read

No economic effects identified for this document.

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## Sources
- [2026-12619 on federalregister.gov](https://www.federalregister.gov/documents/2026/06/24/2026-12619/quantitative-systems-pharmacology-qsp-based-dose-selection-for-minimum-anticipated-biological-effect)
- [2026-12619 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-06-24/pdf/2026-12619.pdf)

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- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-12619 (as of 2026-07-01).