Cures 2.0 Likely To Push US FDA To Further Embrace Real-World Evidence
Draft legislation, which has a good chance of getting wrapped into the next user fee bill, doesn’t give FDA any new authorities or firm mandates on real-world evidence but should nudge agency to more quickly adapt to using RWE for regulatory purposes.
You may also be interested in...
At his Senate confirmation hearing, Robert Califf said he wants to establish a system, built on electronic medical records, that can be used to more quickly confirm the benefits and risks of accelerated approval drugs.
US FDA advisory panel feels there could be a place for Intarcia’s exenatide drug-device combo – if the company is willing to put in the work.
As New Tech Emerges For Early Research, FDA Chief Scientist Says Diversity Must Start In Preclinical Development
In a Pink Sheet interview Chief Scientist Bumpus discusses need to move diversity conversation up further in the pipeline. Better ‘organs on a chip’ should help.