The United States Food and Drug Administration (FDA) is introducing the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH), it was reported on Tuesday.
The US FDA is to continue to build and formalise the coordinating structure and operation of the Digital Health Center of Excellence under its effort to modernise digital health policies and regulatory approaches.
The FDA is naming Bakul Patel as the first director. He has been leading regulatory and scientific efforts related to digital health devices at the US FDA since 2010.
BioCryst wins FDA approval for oral HAE prophylaxis in young children
NanOlogy launches drug development program for diffuse intrinsic pontine glioma treatment
FDA grants priority review to Bristol Myers Squibb's Opdivo regimen for advanced Hodgkin lymphoma
Zydus Lifesciences enters licence and supply partnership with Formycon
Cereno Scientific's Phase IIb trial of CS1 in PAH approved by US FDA
ALR Technologies announces GluCurve Pet CGM relaunch in Canada
Mirum Pharmaceuticals to acquire Bluejay Therapeutics for HDV treatment
PureTech clears key FDA milestone for Phase 3 development of deupirfenidone
J & D Pharmaceuticals' investigational therapy for HCC receives US FDA Orphan Drug Designation
FDA lifts partial clinical hold on Vanda Pharmaceuticals' tradipitant for motion sickness