Zelboraf Approval Hastened By FDA Officials Impressed With Early Efficacy
Supported by robust data demonstrating knock-out response rates, Roche/Genentech’s Zelboraf (vemurafenib) has sailed through the FDA approval process, aided by a push from the agency.
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FDA Expanded Access Guidances Fail To Achieve Détente With Advocates
The number of requests to use investigational drugs outside of clinical trials has grown and FDA typically approves all requests, but advocates still insist the process is set up to fail patients.
Clinical Trial Enrichment Could Require Post-Market Studies, Labeling To Address Shortcomings
FDA’s guidance on clinical trial enrichment notes that a lack of information on patients without the enrichment characteristic may result in Phase IV studies to characterize a drug’s safety and efficacy in a broader population.
FDA On Personalized Medicine: Don’t Skimp On Diagnostic Quality Development
A Center for Devices and Radiological Health representative tells a conference on drug/diagnostic co-development that it doesn’t matter how well designed a study for a therapeutic agent is if the accompanying biomarker-targeted test is not reliable and uniformly implemented.