2027 Biosimilars Medical Records 
pharmaphorum
FEBRUARY 23, 2021
IQWiG sees far less promise in other RWE sources such as electronic medical records and billing records of insurers. The registry study will presumably feed into the longer-term assessment of additional benefit, expected in 2027. The results of this won’t come out until November 2021 and will be seen as provisional.
FDA Law Blog: Biosimilars
MAY 13, 2024
FDA believes that RWE has the power to “accelerate medical product development and bring new innovations and advances faster and more efficiently to the patients who need them, without compromising patient safety.” Every use of ESD is recorded, as is every behavior that falls within the intended use.
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