"Cures requires the Food and Drug Administration to evaluate its trial designs and issue guidance for the purposes of 'incorporating complex adaptive and other novel trial designs.'"
"As with all landmark laws, I think it is critical that the Congress, especially the relevant authorizing committee, engage in oversight to ensure that the agencies are implementing the law according w..."
"I think that is likely to have a significant impact."
"I always got the impression that when Hepatitis C, when SOVALDI came down the pike, that the payers at the State level, certainly the Medicaid payers, were not ready for what was happening."
"The 21st Century Cures Act provides hope to those who need it the most--individuals and families suffering from life-altering, often life-threatening illnesses."
"I always felt while we were doing the roundtables for Cures, that that is likely where the big money was."
"I think you are to be congratulated for that."
"We need to ensure that patients with substance use disorder have access to the treatment they need and we do not unintentionally limit access."
"Patients need transparency into the quality of addiction treatment of the providers nationwide."
"H.R. 6 did pass through this committee and, indeed, on the floor of the House. And we do call on the Senate, the other body, to take that up."
"We need additional resources for Federal, State and local law enforcement."