Policy

Regulatory Oversight

The development of personalized medicine may require that regulatory bodies adopt some new approaches to product approval. This will entail new guidance about the processes for obtaining approval to commercialize new therapeutics, including when and under what circumstances the use of a new drug must be preceded and/or accompanied by the use of a diagnostic or screening test. These clinical trial rules will influence the drug, biotechnology, diagnostic and device industries.

Personalized Medicine Regulation: Pathways for Oversight of Diagnostics outlines and examines the laws and regulations that govern personalized medicine diagnostics so that all stakeholders can share a common understanding of the current system.

The complete paper may be accessed here.

FDA Personalized Medicine Guidance Table

PMC policy positions:

• Draft Guidance for Industry and Food and Drug Administration Staff - In Vitro Companion Diagnostic Devices
• PMC Comments on Development of Companion Diagnostics and the April 2005 Food and Drug Administration (“FDA”) Drug-Diagnostic Co-Development Concept Paper-December 2009 (PDF)
• Draft Report to the Secretary of Health and Human Services (HHS), U.S. System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of HHS (PDF)
  
• Secretary's Advisory Committee on Genetics, Health, and Society Draft Report on Pharmacogenomics
• Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays (IVDMIA) (PDF)
  
• FDA Guidelines for Submission of Pharmacogenomic Data

Policy background:

• CLIA and Genetic Testing