Office Of Combination Products Should Coordinate, Not Review Rx/Dx Products, Roche Says
This article was originally published in The Pink Sheet Daily
Executive Summary
"Partner" products should be reviewed and approved by their respective division, Roche Regulatory Affairs Director Lois Hinman, PhD, says. FDA's draft guidance on co-development of drug/diagnostic products is expected by year-end. The agency is finalizing its pharmacogenomics data submission guidance.