Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Guidance for Industry - Draft Guidance
FDA-2023-D-5016-0002Other
Comments
55
Last activity Jun 24, 2026
Deadline
Closed on Mar 1, 2025
Closed Mar 1, 2025
Net supportiSupport minus oppose · campaigns included
+60%
+60% excluding campaigns
Document
Details
The document's own metadata, straight from the source system.
- Title
- Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Guidance for Industry - Draft Guidance
- Posted
- Dec 30, 2024
- Comment period
- Dec 30, 2024 – Mar 1, 2025
- Topics
Analysis
Overview
What the public is saying — stance, who's commenting, and the issues they raise.
Include campaigns
Stance breakdown
+60%
Net support
Support34Oppose1Other20
Aggregates include form-letter campaigns. Excluding them, net support is +60% across organic comments.
Who commented
Breakdown by commenter type.
Academic
1
Business
11
Individual
28
Advocacy
9
Trade association
4
Other
2
Comments over time
Weekly arrivals, stacked by stance.
Posted Dec 30, 2024Deadline Mar 1, 2025
Dec 30Jan 13Feb 3Feb 17Mar 3Jun 22
Support34Oppose1Other20
Support × commenter type
How each type splits across stance.
Support
Oppose
Other
Individual
43%
4%
54%
Business
73%
0%
27%
Advocacy
89%
0%
11%
Trade association
100%
0%
0%
Other
50%
0%
50%
Academic
100%
0%
0%
Issues raised
The docket's canonical issues. Select one to browse its comments.
Classification of protocol deviations9
Reporting responsibilities for deviations3
Guidance specificity and rigor2
Clarity of clinical investigation scope1
Clarity of sponsor approval1
Definition of protocol components1
Definition of quality issues1
Definition of serious noncompliance1
Guidance on governance and metrics1
Inclusion of cros1
Position map
Who stands where on each issue?
Every non-silent position is backed by an excerpt from the comment.
Issues shown
Choose up to five.
| Organization | International harmonization of reporting thresholds |
|---|
1 organization-typed comment could not be identified.
Comments
Explorer
Every mirrored comment — filter by stance, campaign, or issue.