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.

Medical Records 111

Medical Records Documentation 111

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.

Biosimilars 90

Biosimilars Medical Records 90

Syner-G

JULY 7, 2023

Cell and gene therapies have been subjects of research for some time, but they have gained traction in real-world medicine and are projected to reach a market value of more than $36 billion by 2027. This approach, however great its promise for prediction, diagnosis, minimized side effects, and improving outcomes, has its challenges.

Medical Records 52

Medical Records Drug Development Dosage 52