User Fee Bill Reemerges In Senate With Minor Tweaks, But More Changes Expected
This article was originally published in The Pink Sheet Daily
The new bill includes a provision requiring FDA to consider foreign clinical trial data when making approval decisions and more patient participation in drug development meetings. A cloture vote could come as soon as May 17 with floor debate possibly beginning next week, Sen. Reid says.
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Advocates also are not sure whether to push for a long-term PEPFAR reauthorization; the U.S. expects to release a PEPFAR spending blueprint along with future goals shortly.
After about a week of debate, the Senate overwhelmingly passes its FDA user fee package, with only track and trace to be finalized. House members are scheduled to begin floor debate after Memorial Day in the hopes of sending the bill to President Obama before July 4.
System standards could be included in the manager’s amendment, which was not complete May 18. A cloture vote could come late May 21, which would delay the start of floor debate.