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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:

Policy background:

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