Vendor Inspections Hold Up Wright's Augment Graft Approval
This article was originally published in The Gray Sheet
Wright received an "approvable" letter from FDA about nine months ago for its Augment biologic-device bone graft, but the approval is delayed as the agency performs multiple inspections and has issued two Form-483s to a component supplier for the product.
You may also be interested in...
Firm expects to gain PMA approval in 2013 for BioMimetic’s Augment bone graft as a replacement for autologous bone graft in foot and ankle fusion procedures. Deal includes $190 million down, and up to $190 million more in milestone payments.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
A review by a government watchdog found the FDA’s review process for COVID-19 diagnostics was plagued by issues including allowing low-quality tests to slip through, high reviewer workloads, and manufacturer frustration.