A clinical study conducted under the Critical Path Initiative could provide drug developers with a means to differentiate harmful from benign QT prolongation and allow an earlier determination of whether a compound poses a risk of causing Torsade de Pointes, a potentially fatal abnormal heart rhythm.
FDA Seeks Alternatives To QT Interval For Assessing Risk Of Torsade de Pointes
A clinical study funded by the Critical Path Initiative is looking at the change in a number of electrocardiogram parameters in patients given drugs known to prolong the QT interval and with varying risks for the abnormal heart rhythm.
More from United States
In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."
A former CMS manager worries casework and other necessary functions could suffer as a result of the 300 staff cuts at the agency that are part of a massive HHS restructuring.
The April departures of Paul Kluetz and Marc Theoret follow resignations by other senior agency scientific staff and come on top of HHS’ plans to lay off 3,500 FDA employees.
Pink Sheet reporter and editors discuss how staff may not be the only thing the FDA could lose with the latest layoffs announced by the Health and Human Services Department.
More from North America
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
About 3,500 full-time FDA employees are expected to be laid off as part of a restructuring of the Health and Human Services Department and experts questioned whether the cuts could be implemented without harming FDA’s core mission.
The General Services Administration’s updated list of “assets identified for accelerated disposition” does not include any buildings at the agency’s headquarters in White Oak, MD after its original list of “non-core” government properties for disposal had more than half the buildings on campus.