Biomarkers, Communications Are Key To Accelerating R&D, FDA Says
Executive Summary
Genentech's Herceptin is a good example of how the tradeoffs in targeted drug development can work out medically and commercially, FDA Commissioner McClellan told an IBC meeting in Boston Aug. 12
You may also be interested in...
Abbott Rx For R&D Includes Tandem Drug/Biologic Development
Developing biologics and drugs in tandem for the same target is one method Abbott is using to improve R&D productivity
Abbott Rx For R&D Includes Tandem Drug/Biologic Development
Developing biologics and drugs in tandem for the same target is one method Abbott is using to improve R&D productivity
FDA Revising Accelerated Approval Standard In Oncology; Biomarkers Sought
FDA is changing its accelerated approval guidelines to allow for approval of several different oncologic agents for the same indication under Subpart H procedures, Commissioner McClellan said during the American Society of Clinical Oncology annual meeting in Chicago May 31