September 21, 2019 Off

FDA kicks off pilot program for recognizing qualified accreditation bodies who would accredit testing laboratories

By Dino Mustafić

The U.S. Food and Drug Administration issued a draft guidance Friday outlining the goals and implementation of a new voluntary conformity assessment initiative, the Accreditation Scheme for Conformity Assessment (ASCA) Pilot, designed to promote consistency and predictability in the premarket review process for medical devices, encourage effective use of FDA resources, and enhance regulatory efficiency, while also enhancing confidence in medical device testing.

September 21, 2019 Off

NIH funds awards for national early psychosis learning community

By Dino Mustafić

The National Institutes of Health awarded six research grants for studies to develop a learning health care system for the treatment of early psychosis, as part of a broad research initiative called Early Psychosis Intervention Network (EPINET), which aims to develop models for the effective delivery of coordinated specialty care (CSC) services for early psychosis.