A Case Study in Regulatory Innovation: Pharmacogenomics at FDA
This article was originally published in RPM Report
FDA’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.
You may also be interested in...
From “Safe Harbor” To Spotlight: Pharmacogenomics Comes Of Age At FDA
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.
Commissioner Hamburg on R&D Productivity
The following is an excerpt from FDA Commissioner Margaret Hamburg’s keynote address to the Food & Drug Law Institute annual meeting in Washington April 4.
FDA Rethinking Weight Loss Standards: A Test Case for Patient-Focused Drug Development
The Center for Drug Evaluation & Research is working with George Washington University as a “neutral convener” to rethink weight loss drug development standards. That may make for an unexpected legacy from the wave of failed weight loss candidates from 2010: a whole new approach to drug development guidance from FDA.