FDA, Industry To Iron Out Branding Provision Concerns Under MDUFMA
This article was originally published in The Gray Sheet
Implementation of device branding practices that are cost-effective and do not compromise safety and efficacy will require administrative solutions generated by manufacturers and FDA, according to Latham & Watkins Associate John Manthei
You may also be interested in...
FDA will give manufacturers 18 months to implement branding provisions of the Medical Device User Fee & Modernization Act upon issuance of a final guidance explaining how firms may achieve compliance
FDA is retaining its 510(k)-exempt status for non-electric biopsy forceps, despite a further layer of scrutiny afforded by the Medical Device User Fee & Modernization Act
The European public assessment report for Kaftrio shows that EU regulators had concerns about whether Vertex’s triple drug combination for cystic fibrosis represented a new treatment paradigm.