The Artificial Intelligence Council takes over the work that three different entities in the US FDA’s drugs center had been performing. The new, centralized entity will develop and promote consistency of AI-related activities and advance innovative uses.
The US FDA’s Center for Drug Evaluation and Research is consolidating oversight and coordination of all internal and external artificial intelligence efforts into one centralized entity.
The new Artificial Intelligence Council will coordinate, develop, support and promote consistency of AI-related activities in the drugs center and...
Pink Sheet reporter and editors discuss the likely impacts of Center for Drug Evaluation and Research Director Richard Pazdur’s retirement from the FDA and Tracy Beth Høeg becoming the center’s acting director.
Approval decisions for the FDA's CNPV pilot program will be made by product center officials, but it's unclear if the responsibility lies with center directors or review office leaders.
Pink Sheet reporter and editors discuss the likely impacts of Center for Drug Evaluation and Research Director Richard Pazdur’s retirement from the FDA and Tracy Beth Høeg becoming the center’s acting director.
It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
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.
