Real-World Evidence Could Become Effective Tissue-Agnostic Carving Knife
The data may be different, but US FDA will consider real-world evidence to add a tissue-agnostic indication, as well as take it away.
You may also be interested in...
Bayer's Efforts To Pioneer Tumor-Agnostic Market In Europe Held Back
Bayer’s drive to lead a new market opportunity in Europe for histology-independent cancer agents like Vitrakvi has been set back by interim decisions from the UK’s NICE and Germany’s IQWiG, but there is a now a clear pathway to follow.
Real-World Evidence: Observational Studies Deserve More Respect In US FDA Framework
Biopharma industry urges agency to open the door wider to use of non-randomized observational studies to support efficacy claims, but insurer Kaiser Permanente calls such studies problematic.
US FDA Is Hesitant About Using Observational Studies In Real-World Evidence Framework
Agency plans guidance on whether observational studies can provide real-world evidence to support regulatory decisions about drug effectiveness; however, RWE framework includes critical questions about retrospective studies, and reflects agency concerns about transparency.