ViaCell, Incannounced today the United States Food and Drug Administration (FDA) has conditionally approved its Investigational Device Exemption (IDE) to evaluate its ViaCyte(SM) investigational product offering for the cryopreservation and thawing of human
oocytes for use during assisted reproductive technology.
ViaCell
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
Indianapolis Firm Called Out for Complaint Investigations
The facility lacked adequate procedures for quality audits, the agency found.
Aquestive Petitions FDA to Halt Approval of NDA for Emergency Seizure Spray
Aquestive submitted a rolling NDA for its own seizure cluster drug in May.
FDAnews Device Daily Bulletin
VIACELL FINALIZES IDE AND ANNOUNCES PLANS TO COMMENCE CLINICAL TRIAL OF VIACYTE IN OOCYTE CRYOPRESERVATION
June 28, 2006
