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Power to the Patient with Patient Generated Health Data

FDA Law Blog

Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.

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AstraZeneca’s COVID-19 vaccine; Type 1 diabetes research updates; FDA nod to Zebra’s X-ray modelling AI; UniQure/CSL haemophilia B gene therapy curbs bleeding in phase 3

Delveinsight

The body’s immune system falsely attacks insulin-making beta cells in the pancreas in Type 1 diabetes. Scientists at the University of Utah School of Medicine have found a way to control that autoimmune response by aiming a protein that is vital for T-cell activation. The Lancet paper offers background on how the U.K.