Untimely Tissue Standards Can Stall Product Development – CBER Rep
This article was originally published in The Gray Sheet
Executive Summary
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
You may also be interested in...
Wyeth BMP-2 Panel Review Signals “Not Approvable” Issues Are Resolved
Wyeth is reinterpreting clinical data from a 450-patient pivotal study supporting a BMP-2 premarket approval application
Tissue Product Premarket Route, Legal Framework Debated By EU Regulators
The submission of European tissue product premarket filings to a "central expert body" comprising member state representatives is one of various review options explored by the European Commission in a July consultation document
Roche Gets Adjuvant ALK+ Lung Cancer To Itself With Alecensa Approval
The US FDA cleared Roche’s supplemental approval request for ALK inhibitor Alecensa in ALK-positive non-small cell lung cancer following tumor resection.