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.
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As Senate Heads To Tuesday Vote With McCain Present, GOP Leaders Assure Lawmakers They Could Still Stop Conferenced Bill
Senate Republican leaders are making a last-ditch attempt to woo moderates who aren’t ready to support the Better Care Reconciliation Act on the eve of a planned vote on a motion to proceed with debate by assuring them they would have another opportunity to weigh in because a Senate-passed bill would be melded with the House version in conference.
House Dems To Meet On ACA Fix Ideas As Senate GOP Holds Key Health Care Vote
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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.
A highly contested and yet-to-be-finalized rule on generic drug labeling has been moved from immediate priority to long-term priority on the White House Office of Management and Budget's road map for the year's upcoming regulations.
FDA is stopping work on several key rules including those regulating compounding, direct-to-consumer prescription drug advertising, child-focused tobacco sales, dietary supplement manufacturing practices and food safety testing, according to a list published Friday (July 21) by the White House Office of Management and Budget.
FDA faces pressure from stakeholders to increase transparency around the citizen petition process, product hopping and other tactics used by brand makers to delay generic drugs from entering the market.
FDA faced pressure from a variety of stakeholders to take several specific steps to stop brand drug makers from using Risk Evaluation and Mitigation Strategies (REMS) to delay generic drug marketing -- but also faced push-back from the brand pharmaceutical and biologics lobbies to some of the ideas raised at a public meeting this week.
In response to drug makers, CMS is considering undoing the policy of putting biosimilars that reference the same brand biologic in common billing...
Senate Majority Leader Mitch McConnell (R-KY) signaled that the committees of jurisdiction could continue with health reform through regular order...
FDA and its advisers are struggling to decipher whether Congress' definition of real-world evidence excludes data gathered as part of a single-arm...
