Should FDA Be Forced To Consider Development Time And Cost?
Executive Summary
Venture capitalist suggests the agency should keep both issues in mind when it orders a sponsor to conduct more trials or submit additional data in order to bring down the cost of drug development.
You may also be interested in...
Patent Incentives Pitched As Part Of Corporate Tax Reform
European-style 'patent box' recommended by former Allergan CEO at Senate hearing.
21st Century Cures: Data Reliance Provision May Raise Exclusivity Issues
FDA can use previously generated data when reviewing rare disease drugs targeted at small subsets.
FDA Budget Issues Creep Into Strategic Priorities
“Given the limited availability of investment capital for medical product development, early clarification of regulatory requirements is critical,” FDA says. Agency officials included stewardship, such as doing more with less funding, among the cross-cutting strategic priorities in its draft strategic priorities document for 2014-2018.