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User Fee Amendments In Senate Filed, But Track-And-Trace Remains Off The Map

This article was originally published in The Pink Sheet Daily

Executive Summary

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.

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User Fee Bill Reemerges In Senate With Minor Tweaks, But More Changes Expected

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.

User Fee Legislation Revs Through Senate Mark-up, But House Bill Goes Back Into The Shop

Senate health committee defers action on several potentially contentious issues, with members hoping to resolve differences over FDA’s authorities on imports, shortages, foreign data and track-and-trace before the bill goes to the floor, possibly in May. Meanwhile, the House postpones its mark-up in an effort to craft a more bipartisan bill, and now will try to push the user fee package to the floor during an upcoming four-day marathon session.

Generics Liability Bill Could Face Uphill Road In Senate

Sen. Leahy plans to introduce legislation to overturn the Supreme Court’s ruling in Pliva v. Mensing; the attorney who represented generic manufacturers in that case says the legislation is unlikely to pass.

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