Should FDA Be Forced To Consider Development Time And Cost?
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.
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“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.