Wyeth BMP-2 Panel Review Signals “Not Approvable” Issues Are Resolved
This article was originally published in The Gray Sheet
Executive Summary
Wyeth is reinterpreting clinical data from a 450-patient pivotal study supporting a BMP-2 premarket approval application
You may also be interested in...
Untimely Tissue Standards Can Stall Product Development – CBER Rep
Premature standards development for tissue-engineered medical products (TEMPs) could delay their entry into the market, according to Joyce Frey-Vasconcells, acting deputy director of CBER's Office of Cellular, Tissue & Gene Therapies
Untimely Tissue Standards Can Stall Product Development – CBER Rep
Premature standards development for tissue-engineered medical products (TEMPs) could delay their entry into the market, according to Joyce Frey-Vasconcells, acting deputy director of CBER's Office of Cellular, Tissue & Gene Therapies
Medtronic InFuse PMA Approval Sets Up CMS “New Technology” Add-On
FDA's July 2 approval of Medtronic Sofamor Danek's InFuse bone graft/LT-Cage lumbar tapered fusion system arrives in time for the device to qualify for a Medicare "new technology" add-on payment