An FDA inspection cites multiple quality control and aseptic processing concerns at Staska Pharmaceuticals.
FDA posts updated guidance outlining how drugmakers should design clinical development programs for new tuberculosis treatments, emphasizing the need for shorter, safer and more effective regimens.
An FDA inspection cites multiple quality control and aseptic processing concerns at Staska Pharmaceuticals.
FDA posts updated guidance outlining how drugmakers should design clinical development programs for new tuberculosis treatments, emphasizing the need for shorter, safer and more effective regimens.
FDA delays by three months its decision on Eisai and Biogen's subcutaneous starting-dose formulation of Alzheimer’s drug Leqembi (lecanemab) after the agency requested additional information during its review.
A legal analysis published by Crowell & Moring says a proposed FDA pilot program on artificial intelligence in early-stage clinical trials could shape future agency expectations for how sponsors validate, document and oversee AI systems used in clinical research.
