FDA, European Approaches To Stryker OP-1 Data Produce Conflicting Results
This article was originally published in The Gray Sheet
Executive Summary
FDA's "non-approvable" letter for Stryker's OP-1 bone growth factor PMA for treating nonunion fractures was prompted by insufficient radiographic data, as opposed to clinical outcomes.
You may also be interested in...
Stryker Will Discuss Rejected OP-1 PMA At Upcoming Meeting With FDA
Stryker expects to meet with FDA by March 1 to discuss the agency's "not approvable" letter for OP-1 bone growth factor for treating nonunion fractures.
Stryker's ABC Ceramic Hip Prosthesis Gains Panel Nod, Trident Shot Down
Stryker's second-generation Trident ceramic-on-ceramic hip arthroplasty device is sufficiently different from its predicate ABC (aluminum bearing couple) hip prosthetic to warrant a separate set of data for regulatory approval, FDA's Orthopedic and Rehabilitation Device Panel concluded at a July 20 meeting in Gaithersburg, Maryland.
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.