A Case Study in Regulatory Innovation: Pharmacogenomics at FDA
This article was originally published in RPM Report
Executive SummaryFDA’s idea to encourage “voluntary” submission of pharmacogenomic data started slow—but the program has paid significant dividends for the agency. In addition to building knowledge and advancing the use of PKG in drug regulation, it has also won over industry and become a case study to support broader funding of regulatory science.
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An FDA/industry workshop on pharmacogenomics and biomarkers highlighted how far the regulatory system for PKG has evolved. Where industry was afraid to share data with FDA, the conversation is now about how to get the agency the resources it needs to review the data effectively.