The House Energy and Commerce Committee Democrat says few in-depth member talks about user-fee bills have taken place because of a focus on Affordable Care Act repeal and replacement.
US FDA's user-fee renewal seems to have taken a backseat temporarily to Obamacare reform on Capitol Hill, and discussions to build the necessary legislation now may be behind schedule.
Rep. Diana DeGette, D-Colo., said Feb. 8 that FDA staff now are talking to Hill staff about user-fee agreements, including...
A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.
An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.
The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.
Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it.
An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.
A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
