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.
- 25 comments from the past week
25 comments match your current view and arrived in the last week. Read this week's comments with stance, commenter type, and AI summaries on the paid plan.
- Jul 27, 2026Comment from Walter LynneOpposeIndividual
A patient expresses concern over the FDA's reclassification of desiccated thyroid extract (DTE) as a biologic. The commenter argues that this change will create barriers to access, increase costs, and eliminate options for patients who rely on DTE from compounding pharmacies.
Read comment → - Jul 27, 2026Comment from Kirby MelissaOpposeIndividual
A patient expresses concern over the FDA's reclassification of desiccated thyroid extract (DTE) as a biologic. The commenter argues that this change will create barriers to access, increase costs, and eliminate options for patients who rely on DTE from compounding pharmacies.
Read comment → - Jul 27, 2026Comment from Miller TinaOpposeIndividual
A patient expresses concern over the FDA's reclassification of desiccated thyroid extract (DTE) as a biologic. The commenter argues that this change will create barriers to access, increase costs, and eliminate options for patients who rely on DTE from compounding pharmacies.
Read comment → - Jul 27, 2026Comment from Hay NoahOpposeIndividual
A patient expresses concern over the FDA's reclassification of desiccated thyroid extract (DTE) as a biologic. The commenter argues that this change will create barriers to access, increase costs, and eliminate options for patients who rely on DTE from compounding pharmacies.
Read comment → - 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 → - Jul 27, 2026Comment from Lasecki BeckyOpposeIndividual
A patient expresses concern over the FDA's reclassification of desiccated thyroid extract (DTE) as a biologic. The commenter argues that this change will create barriers to access, increase costs, and eliminate options for patients who rely on DTE from compounding pharmacies.
Read comment → - Jul 27, 2026Comment from Houriet KathrynOpposeIndividual
A patient expresses concern over the FDA's reclassification of desiccated thyroid extract (DTE) as a biologic. The commenter argues that this change will create barriers to access, increase costs, and eliminate options for patients who rely on DTE from compounding pharmacies.
Read comment → - Jul 27, 2026Comment from Franchini,BarbaraOpposeIndividual
An individual patient expresses opposition to the FDA's reclassification of desiccated thyroid extract (DTE) as a biologic. They argue that this change will create barriers to access, increase costs, and eliminate the ability of compounding pharmacies to provide a treatment that is essential for their health.
Read comment → - Jul 27, 2026Comment from Olivera RhondaOpposeIndividual
A patient expresses concern over the FDA's reclassification of desiccated thyroid extract (DTE) as a biologic. The commenter argues that this change will create barriers to access, increase costs, and eliminate options for patients who rely on DTE from compounding pharmacies.
Read comment → - Jul 27, 2026Comment from OConnor DonnaOpposeIndividual
An individual patient expresses opposition to the FDA's reclassification of desiccated thyroid extract (DTE) as a biologic. They argue that this change will create barriers to access, increase costs, and eliminate the ability of compounding pharmacies to provide a vital treatment for patients who cannot tolerate synthetic medicines.
Read comment →
