A bipartisan letter from the leaders of the House Energy and Commerce Committee’s Health Subcommittee indicates the FDA’s efforts to revamp the review structure for cell and gene therapies will be closely watched by key legislators.
The US Food and Drug Administration’s overhaul of the cell and gene therapy product review divisions will be tracked by a key congressional committee, which is expecting tangible signs of improvement in communication with sponsors.
A 28 March letter to the agency from the top Republican, Kentucky’s Brett Guthrie, and Democrat, California’s Anna Eshoo,...
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.
Long-term follow-up requirements have taken a conservative approach but could be ripe for re-examination and global harmonization given the years of experience with the products, Kite Pharma executive director says; former FDA gene/cell therapy office head Wilson Bryan calls for elimination of the classwide REMS.
Program for collaborative reviews of gene therapy applications is getting under way with the European Medicines Agency. After launch, the pilot could be expanded to earlier discussions around CMC and pharm/tox data requirements, FDA’s Nicole Verdun said.
