The "Deemed To Be a License" Provision of the BPCI Act; Questions and Answers; Guidance for Industry

A healthcare prescriber opposes the FDA's reclassification of desiccated thyroid extract (DTE) as a biologic. They argue that this change restricts patient access to an effective therapy, reduces clinical choice, and is based on a shift in regulatory posture rather than new safety data.

A healthcare prescriber opposes the FDA's reclassification of desiccated thyroid extract (DTE) as a biologic. They argue that this change restricts patient access to an effective therapy, reduces clinical choice, and is based on a shift in regulatory posture rather than new safety data.

A healthcare prescriber opposes the FDA's reclassification of desiccated thyroid extract (DTE) as a biologic. They argue that this change restricts patient access to an effective therapy, reduces clinical choice, and is based on a shift in regulatory posture rather than new safety data.

A healthcare prescriber argues against the FDA's reclassification of desiccated thyroid extract (DTE) as a biologic. They contend that DTE is a necessary treatment for certain patients and that the reclassification will restrict patient choice, increase costs, and remove compounding pharmacies from the supply chain.

A healthcare prescriber argues against the FDA's reclassification of desiccated thyroid extract (DTE) as a biologic. They contend that DTE is a necessary treatment for certain patients and that the reclassification will restrict patient choice, increase costs, and remove compounding pharmacies from the supply chain.

A healthcare prescriber argues against the FDA's reclassification of desiccated thyroid extract (DTE) as a biologic. They contend that DTE is a necessary treatment for certain patients and that the reclassification will restrict patient choice, increase costs, and remove compounding pharmacies from the supply chain.

A healthcare prescriber argues against the FDA's reclassification of desiccated thyroid extract (DTE) as a biologic. They contend that DTE is a necessary treatment for certain patients and that the reclassification will restrict patient choice, increase costs, and remove compounding pharmacies from the supply chain.

A healthcare prescriber argues against the FDA's reclassification of desiccated thyroid extract (DTE) as a biologic. They contend that DTE is a necessary treatment for certain patients and that the reclassification will restrict patient choice, increase costs, and remove compounding pharmacies from the supply chain.

A healthcare prescriber argues against the FDA's reclassification of desiccated thyroid extract (DTE) as a biologic. They contend that DTE is a necessary treatment for certain patients and that the reclassification will restrict patient choice, increase costs, and remove compounding pharmacies from the supply chain.

A healthcare prescriber opposes the FDA's reclassification of desiccated thyroid extract (DTE) as a biologic. They argue that this change restricts patient access to an effective therapy, reduces clinical choice, and is based on a shift in regulatory posture rather than new safety data.