The "Deemed To Be a License" Provision of the BPCI Act; Questions and Answers; Guidance for Industry
Details
The document's own metadata, straight from the source system.
- Title
- The "Deemed To Be a License" Provision of the BPCI Act; Questions and Answers; Guidance for Industry
- Posted
- Mar 5, 2020
- Comment period
- Mar 5, 2020 – ?
- Topics
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.
Campaigns
Organized form-letter drives, separated from organic one-off comments.
Explorer
Every mirrored comment — filter by stance, campaign, or issue.
- Jul 27, 2026Comment from Bernhard MelodieOpposeIndividual
Melodie Bernhard, a patient, opposes the FDA's reclassification of desiccated thyroid extract (DTE) as a biologic. She argues that the reclassification will create barriers to access, increase costs, and eliminate a vital treatment option for patients who do not respond well to synthetic medications.
Read comment → - Sep 26, 2025Comment from Walker AlexSupportIndividual
Alex, an individual, expresses strong opposition to the use of Desiccated Thyroid Extract (DTE). They support the FDA's action to reclassify and remove the product from the market due to safety concerns.
Read comment →