Ortec International, Inc., a company focused on development and commercialization of products applicable to regenerative medicine and stem cell therapy, May 30 announced that as a result of ongoing discussions with the Food and Drug Administration (FDA), Ortec expects to file an HDE supplement to obtain marketing approval for use of OrCel in RDEB patients by mid-July 2006.
Yahoo News
Simplifying Global Compliance
Recommended Products
EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements
The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition
Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval.
Editor's Picks
Lax Quality Observed at Device Facility in China
The company failed to investigate a customer complaint about a malfunctioning device.
Three Breast Cancer Drugs Pose Risks of Lung Inflammation, FDA Says
Possible symptoms include shortness of breath while resting or during low physical activity, the agency said.
FDAnews Device Daily Bulletin
ORTEC EXPECTS TO FILE HUMANITARIAN DEVICE EXEMPTION (HDE) APPLICATION WITH FDA REQUESTING MARKETING APPROVAL OF CRYOPRESERVED ORCEL FOR USE IN EPIDERMOLYSIS BULLOSA PATIENTS
June 1, 2006
