Category: North America

September 23, 2019 Off

GW paves way to launch Epidylex in Europe

By Dino Mustafić

GW Pharmaceuticals paved a way to launch Epidyolex in Europe, for use as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients 2 years of age and older.

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The U.S. Food and Drug Administration issued a draft guidance Friday outlining the goals and implementation of a new voluntary conformity assessment initiative, the Accreditation Scheme for Conformity Assessment (ASCA)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.