[Editor's note: A version of this story appeared first in our sister publication, Pink Sheet.]
The month of September will herald the first fully in-person US Food and Drug Administration advisory committee meeting on a...
The 9 September meeting on Iterum Therapeutics' oral sulopenem product for uncomplicated urinary tract infections marks the first fully in-person advisory committee drug review since the COVID-19 pandemic hit in early 2020.
[Editor's note: A version of this story appeared first in our sister publication, Pink Sheet.]
The month of September will herald the first fully in-person US Food and Drug Administration advisory committee meeting on a...
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.
To succeed in medtech, investors must focus on patient outcomes. Gilde Healthcare says involving patients boosts product effectiveness, access and market success — making it a smart strategy in today’s strained healthcare systems.