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 FDA's draft guidance on co-development of drug/diagnostic products is expected by year-end.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.
You may also be interested in...
Pharmacogenomics Public Workshop Planned For April 2005
The meeting will follow release of an FDA draft guidance on the co-development of pharmacogenomic tests with a drug or biologic, which is expected by the end of the year.
Pharmacogenomics Public Workshop Planned For April 2005
The meeting will follow release of an FDA draft guidance on the co-development of pharmacogenomic tests with a drug or biologic, which is expected by the end of the year.
FDA's Initiatives Will Not Be Affected By Election Results, Crawford Says
Efforts to develop guidance on pharmacogenomics and combination Rx/Dx products are "progress in the making" and not vulnerable to changes in political leadership, FDA Acting Commissioner Crawford maintains.