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Policy Category: Public Policy

Personalized medicine benefits patients and may also make the health care system more efficient, but a paradigm shift in medicine will not happen just because the science suggests it should. Policies matter.

With that in mind, the Coalition’s members engage on many public policy topics, including:

Evidence development
Government innovation
Intellectual property
Regulation
Reimbursement
Research funding
Value in health care

Reauthorization of the FDA’s Prescription Drug User Fee Program

Medicare Payments for Chimeric Antigen Receptor T-Cell Therapies

FY 2026 Funding Appropriations for NIH

Inflation Reduction Act/Medicare Drug Price Negotiation Program

FY 2026 Funding Appropriations for FDA

FY 2026 Funding Appropriations for NIH

Federal Data Privacy Legislation

FDA Draft Guidance on AI in Regulatory Decision-Making for Drugs and Biologics

FDA Draft Guidance on AI-Enabled Device Software Functions

Encouraging the Continued Development of Personalized Treatments Under the Inflation Reduction Act: PMC Letters of Support for the EPIC, ORPHAN Cures, and MINI Acts

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