FDALegislativeWatch

FDA Reform Bill Could Still Face Administrative Gauntlet After Enactment

FDA has yet to determine how quickly it can exercise new authorities created by the FDA Amendments Act of 2007, agency officials told reporters Sept. 27, a few hours after President Bush signed H.R. 3580 into law.

FDA Bill Passes; Congress Adds $225 Million To Industry User Fee Burden

Final FDA reform legislation that cleared Congress adds an additional $225 million to industry's user fee tab over five years, but limits penalties that FDA can assess to enforce its new authorities to mandate labeling changes and postmarket studies.

Congress Approves FDA Reform/User Fee Bill In The Nick Of Time

Congress gave final approval last week to a massive FDA bill that renews device and drug user fees for five years and strengthens product safety programs.

FDA Reauthorization Steers Clear Of Agency's OTC Authority, DSHEA, AER Law

The FDA reauthorization bill Congress has passed does not rock the boat on FDA's current authority over either over-the-counter switches or dietary supplements.

FDA Reform Bill Clears Congress Despite Temporary Snag In Senate

The Senate passed the new FDA reform bill, H.R. 3580, by unanimous consent Sept. 20, a day after the House adopted the same measure.

Compromise FDA Reform Bill Passes House, Adds $225 Million In User Fees For Drug Safety

The U.S. House of Representatives voted 405-7 Sept. 19 to adopt compromise FDA reform legislation that increases prescription drug user fees by $225 million above the level agreed to earlier by FDA and drug manufacturers for fiscal years 2008-2012.

Import Safety Group Slates "Action Plan" For November Release

The Bush administration's import safety task force plans to lay out a road map for improving the import safety system by mid-November, the group says in a report issued Sept. 10.

House-Cleared Patent Reform Bill Is Likely Not The Final Word

A sponsor of the House-passed patent reform bill indicated that a provision strongly opposed by device firms is likely to be revised before it becomes law.

Congress Down To The Wire On FDA User Fee Reauthorization

FDA reform legislation reauthorizing device and drug user fees may not be finalized by Congress in time to avoid agency layoffs.

Federal Judges Weigh In On Patent Reform, Supreme Court's KSR Ruling

During the House floor debate on patent reform, legislators boasted that they had sought input from all the industries and organizations affected by the legislation. But they apparently overlooked one of the groups most steeped in patent litigation: the U.S. Court of Appeals for the Federal Circuit.