FDA, Industry To Iron Out Branding Provision Concerns Under MDUFMA
This article was originally published in The Gray Sheet
Executive Summary
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...
MDUFMA Branding Provision Reprieve To Be Explained In Upcoming Guidance
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
Device Reuse: 510(k) Exemptions Terminated, Validation Guidance Awaited
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
Generic Or Innovator? Sandoz Sues CMS Over Potential Change In Rebate Classification
Sandoz argued against paying higher rebates for two of its drugs via the Centers for Medicare and Medicaid Services’ Medicaid drug rebate program in a US court six years after the suggestion was first made.