With cell and gene therapies becoming more popular, CBER Director Marks says in an interview with the Pink Sheet that more staff may be needed soon.
Peter Marks isn't sure when it will arrive, but he expects that in the coming years the Center for Biologics Evaluation and Research will need more personnel and resources to handle an expanding workload.
Marks, CBER's director, said in an June 27 interview with the Pink Sheet that his center "may have a certain...
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.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.
