drug review
FDA Launches AI Tool to Accelerate and Transform Drug Review Processes
FDA; AI tool; drug review; rapid review; generative AI; regulatory science; Elsa; automation; application assessment
About 5% of CBER and CDER Left After FDA Staff Cuts, Analysis Finds
FDA layoffs; CBER; CDER; drug review; biologics; staff cuts; Trump administration; drug approval process
Massive FDA Staff Cuts Jeopardize Drug and Device Review Processes, Threatening Critical User Fee Programs
FDA layoffs , Drug review delays , User Fee Programs , PDUFA , Regulatory challenges , FDA budget cuts , Medical device approval , Biopharma regulatory issues , RFK Jr. HHS layoffs , FDA operational disruptions
FDA Enhances Transparency in Drug Review Process with Revised Document Structure
FDA, drug review process, transparency, document structure, regulatory oversight