How to Prepare a Pre-Request for Designation (Pre-RFD) Guidance for Industry
Details
The document's own metadata, straight from the source system.
- Title
- How to Prepare a Pre-Request for Designation (Pre-RFD) Guidance for Industry
- Posted
- Feb 16, 2018
- Comment period
- Feb 16, 2018 – ?
Overview
What the public is saying — stance, who's commenting, and the issues they raise.
Stance breakdown
Who commented
Breakdown by commenter type.
Comments over time
Weekly arrivals, stacked by stance.
Support × commenter type
How each type splits across stance.
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.
Explorer
Every mirrored comment — filter by stance, campaign, or issue.
- Jul 23, 2026Comment from Gordon Wayne DyerSupportBusiness📎 Attachment
Gordon Wayne Dyer, an owner of a product involving tea tree oil, argues that tea tree oil should be classified as an established pre-1938 antiseptic drug rather than a new drug. He contends that the FDA's current regulatory treatment of the substance is inappropriate and is causing delays in the approval of his medical device.
Read comment → - Nov 6, 2020Comment from Dwayne A. HarrisAnalysis pending📎 AttachmentRead comment →