The new job notice offers a top salary, but also invites questions about the candidate pool attracted by the original solicitation.
The search for the inaugural director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products is open again, this time with an increased salary range and telework opportunities that could attract more candidates.
The Office of Therapeutic Products, formerly the Office of Tissues and Advanced Therapies (OTAT), handles cell and gene therapy applications...
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.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.
