The US FDA has implemented significant regulatory changes for medical device manufacturers:The Accreditation Scheme for Conformity Assessment (ASCA), previously in a pilot phase,...
Shares of Novo Nordisk Drop Following FDA Reports of Manufacturing Deficiencies
Novo Nordisk, a global healthcare company, observed a drop in its shares following the FDA's report of manufacturing deficiencies in its Clayton, North Carolina...
Public Consultation Opens for Updates on NICE’s Health Technology Evaluations Manual
A public consultation regarding revisions to NICE's health technology evaluation manual has been initiated. The consultation period, scheduled to last four weeks, will focus...
The Food and Drug Administration (FDA) has released a draft guide to explain how evidence from a single clinical investigation can serve as substantial...
