Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-inHuman (FIH) Trials; Guidance for Industry; Draft Guidance
NonrulemakingOtherFDA-2026-D-6539-0002
Comments
0
Awaiting comments
Deadline
30 days
Closes Jul 25, 2026
Net supportiSupport minus oppose · campaigns included
—
Document
Details
The document's own metadata, straight from regulations.gov.
- Posted
- Jun 24, 2026
- Comment period
- Jun 24, 2026 – Jul 25, 2026
- Agency
- Food and Drug Administration (FDA)
Analysis
Overview
No comments yet — comment period open · 30 days left.
Comments
Explorer
Every mirrored comment — filter by stance, campaign, or issue.
Filter:
No comments match.