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Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-inHuman (FIH) Trials; Guidance for Industry; Draft Guidance

FDA-2026-D-6539-0002Other
Comments
6
Last activity Jul 24, 2026
Deadline
Closed on Jul 25, 2026
Closed Jul 25, 2026
Net supportiSupport minus oppose · campaigns included
0%
0% excluding campaigns
Document

Details

The document's own metadata, straight from the source system.

Title
Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-inHuman (FIH) Trials; Guidance for Industry; Draft Guidance
Posted
Jun 24, 2026
Comment period
Jun 24, 2026 – Jul 25, 2026
Agency
Food and Drug Administration (FDA)
Topics
View on regulations.gov ↗
Analysis

Overview

What the public is saying — stance, who's commenting, and the issues they raise.

Include campaigns
Analyzed 1 of 6 comments
17%· analysis in progress

Stance breakdown

0%
Net support
Other1Not yet analyzed5
Aggregates include form-letter campaigns. Excluding them, net support is 0% across organic comments.

Who commented

Breakdown by commenter type.

Individual
1
Not yet analyzed
5

Comments over time

Weekly arrivals, stacked by stance.

Posted Jun 24, 2026Deadline Jul 25, 2026
Jun 29Jul 6Jul 20
Support0Oppose0Other1

Support × commenter type

How each type splits across stance.

Support
Oppose
Other
Individual
0%
0%
100%

Issues raised

The docket's canonical issues. Select one to browse its comments.

Issues are identified as comment analysis progresses — nothing tagged on this document yet.

Comments

Explorer

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