The FDA is experiencing delays and potential consolidations within operational units such as human resources and communications to address workload challenges. Significant delays in drug application decisions have been announced, including missed PDUFA dates for KalVista Pharmaceuticals, Novavax, GSK, and Stealth BioTherapeutics. FDA Commissioner Marty Makary is considering efficiency measures without affecting application reviews. These developments come amid recent large-scale staffing cuts at the FDA and broader federal health department restructurings.