Streamlining adverse event reports among reform ideas; NIH's Recombinant DNA Advisory Committee likely to drop review of more routine protocols.
Gene therapy sponsors eventually could see their regulatory obligations less beholden to the US National Institutes of Health as FDA assumes more oversight of the maturing field.
Both agencies are working to simplify the requirements, Peter Marks, director of FDA's Center for Biologics Evaluation and Research, said...
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.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.
