Policy Category: Regulation

PMC advises regulators on public policies that can help facilitate the efficient review of personalized medicine products. For example, PMC explained how certain enhancements to the U.S. Food and Drug Administration (FDA)’s drug and medical device user fee programs could help advance personalized medicine while participating in a series of public workshops FDA convened to discuss the user fee programs in 2020, 2021, and 2022. Many of PMC’s recommended changes went into effect with the passage of new user fee reauthorization laws in 2022.

Policy Category: Regulation

FDA Draft Guidance on AI in Regulatory Decision-Making for Drugs and Biologics

FDA Draft Guidance on AI-Enabled Device Software Functions

FDA’s Draft Guidance on Diversity Action Plans

Sen. Bill Cassidy’s Request for Information on Ways to Improve the Regulation of Clinical Tests

FDA Guidance on Pharmacogenomic Data Submissions

U.S. House of Representatives Ways and Means Health Subcommittee Hearing on Policies That Inhibit Innovation and Patient Access

Reauthorization of FDA’s Prescription Drug and Medical Device User Fee Programs

Support for the Nomination and Confirmation of FDA Commissioners

FDA’s Publication of a List of Patient Preference-Sensitive Priorities

Framework for Oversight of Diagnostic Testing in the United States