Wright Medical gets FDA reclassification decision
This article was originally published in Clinica
Executive Summary
Resorbable calcium salt used to fill bony voids or gaps of the extremities, spine and pelvis has been classified by the FDA as a class II, or medium-risk, device subject to special control. The special control is adherence to a new guidance document on the product, the agency said.
You may also be interested in...
Industry & Regulators To Align Advice on COVID-19 Vaccine Updates
A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers to update their vaccines, change their manufacturing processes and prepare approval applications.
Sanofi Skates To Where The Puck Is With Immunology
The French drugmaker has not abandoned oncology but has made it very clear that immunology and inflammation is the priority for its R&D euros.
Pipeline Watch: Five Approvals And 23 Phase III Updates
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.