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.
Merck to acquire Terns Pharmaceuticals for USD6.7bn
Philips launches integrated IntraSight Plus platform to enhance coronary intervention efficiency
Hope Medicine reports first patient dosed in Phase III trial of HMI-115
Orsini chosen as single-source specialty pharmacy partner for Glaukos' Epioxa
Futura Medical reports positive home user test results for Eroxon and Intense variant
GSK secures Japan Orphan Drug status for lung cancer ADC
Belief BioMed enters exclusive partnership with Grand Life Sciences for haemophilia A treatment
Glaukos launches Epioxa to advance incision-free treatment for keratoconus
Sanofi's venglustat receives FDA Breakthrough Therapy designation for type 3 Gaucher disease
Sentynl Therapeutics and PRG S&T enter licensing agreement for potential HGPS treatment
CMIC agrees agentic AI partnership with Bluenote
Biofrontera reports Phase 2b data for Ameluz photodynamic therapy in acne vulgaris treatment
Precision BioSciences receives FDA Fast Track designation for PBGENE-DMD