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.

Comments to Food and Drug Administration Development of Companion Diagnostics and the April 2005 Food and Drug Administration ("FDA") Drug-Diagnostic Co-Development Concept Paper

• Policy Position

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

• Policy Position

Secretary's Advisory Committee on Genetics, Health, and Society
Draft Report on Pharmacogenomics

• Policy Position

Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays (IVDMIA)

• Policy Position

FDA Guidelines for Submission of Pharmacogenomic Data

• Policy Position