The Senate hotlined a bill Wednesday (Aug. 2) afternoon from Sens. Roger Wicker (R-MS) and Amy Klobuchar (D-MN) that seeks to increase the patient's role in FDA's risk-benefit determination for drug approvals.
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The Senate hotlined a bill Wednesday (Aug. 2) afternoon from Sens. Roger Wicker (R-MS) and Amy Klobuchar (D-MN) that seeks to increase the patient's role in FDA's risk-benefit determination for drug approvals.
Sen. Ron Johnson (R-WI) has agreed to pull back his threat to hold up the FDA user fee package in exchange for a commitment that an amended version of his Right to Try legislation will be taken up by unanimous consent as the Senate moves to pass the user fee package Thursday (Aug. 3), sources tell Inside Health Policy.
House Energy & Commerce Committee ranking Democrat Frank Pallone (NJ) is calling for cosmetics to be included in an over-the-counter (OTC) user fee program that is being discussed by FDA and Congress.
Senate Majority Leader Mitch McConnell (R-KY) announced Tuesday (August 1) that Republicans want to vote on the FDA user fee package before the August recess, but one industry source tells Inside Health Policy that while Republicans want to move on the legislation next week, Democratic and Republican leadership have not yet agreed on an amendment package.
Senate Majority Leader Mitch McConnell (R-KY) filed cloture late Tuesday (August 1) on the motion to proceed with the FDA user fee package, setting up a Senate vote on the motion early Thursday.
Sens. Orrin Hatch (R-UT) and Bob Menendez (D-NJ) are attempting to attach the Orphan Product Extensions Now Accelerating Cures and Treatments (OPEN) Act, which would extend exclusivity for orphan drugs by six months, to the user fee package expected to be taken up by the Senate this week, a Democratic lobbyist tells Inside Health Policy.
With the Senate's last-ditch effort to pass an Affordable Care Act repeal bill defeated, sources tell Inside Health Policy that the chamber has yet to settle on a date to consider must-pass FDA user fee reauthorization legislation, but point to the first week of September as a likely timeline.
The medical device lobby will seek to add a rider permanently repealing the medical device tax to the Senate user fee package -- despite previous concerns that the rider could not be added due to jurisdictional issues -- if the tax is not repealed as part of health reform efforts.
The medical device lobby will seek to add a rider permanently repealing the medical device tax to the Senate user fee package -- despite previous concerns that the rider could not be added due to jurisdictional issues -- if the tax is not repealed as part of health reform efforts.
FDA Commissioner Scott Gottlieb wrote to FDA staff Monday (July 24) that the agency will not issue layoff notices to user fee-funded employees until Sept. 30, buoyed by confidence that the user fee package will be signed into law before the existing authorizations lapse.
The Senate is still “hopeful” over-the-counter (OTC) monograph reform language could be added to the FDA user fee reauthorization bill, a spokesperson for Sen. Johnny Isakson (R-GA) told Inside Health Policy.
A leading cancer research advocacy organization is urging the Senate to include in its user fee package a bill that aims to increase development of therapies for childhood cancer.
Senate Majority Leader Mitch McConnell (R-KY) used Rule XIV to place the House-passed user fee package on the Senate calendar Monday (July 17).
The House passed FDA user fee legislation Wednesday afternoon (July 12) by voice vote, and lawmakers pressed the Senate to act quickly on the must-pass reauthorization package to avoid pink slips being sent to FDA employees at the end of the month.
A pre-conferenced FDA Reauthorization Act (FDARA), which is expected to face a House vote Wednesday afternoon, includes portions of a bill aimed at increasing development of childhood cancer drugs.
A revised FDA user fee package set to face a House vote Wednesday afternoon under suspension of the rules largely combines the marked up House and Senate bills, and leaves out legislation crafted by industry and FDA to create an over-the-counter monograph user fee program.
The House is set to send a pre-conferenced FDA Reauthorization Act to the floor Wednesday afternoon for a vote on the user fee package under suspension of the rules, sources tell Inside Health Policy.
A House FDA user fee measure that would use market incentives to boost generic competition for sole-source drugs could be bolstered by FDA chief Scott Gottlieb's newly unveiled list of off-patent drugs that lack competition.
Despite dodging a proposal for much more stringent oversight, one third-party medical device servicers organization is again calling on Congress to further revise a bill that would require FDA to submit a report on how it will ensure the quality and safety of medical devices that have been repaired “by a person other than the manufacturer.”
A draft document obtained by Inside Health Policy sets out expected performance goals for an over-the-counter monograph user fee program (OMUFA) under which FDA would see improved review timelines and more efficient review capacity by year four of the program.
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