If I reference the IOM report again here, in the United States, use of clinical data in the regulatory review process is defined by the enabling legislation, regulations and FDA's implementation of the legislation and regulations.
Senator Hagan discusses the role of clinical data in regulatory review.
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Mr. President, I ask unanimous consent that the Committee on the Judiciary be authorized to meet during the session of the Senate on July 10, 2014, at 9:30 a.m., in room SD-226 of the Dirksen Senate Office Building, to conduct an executive…
Certainly. Obviously, we're talking about those situations where the stories that we've heard this morning and have read about are on the other end of that spectrum.
We are also thankful to those on this committee who have been supportive of this bill, including Senator Casey of Pennsylvania and Senator Kay Hagan of North Carolina.
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