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FDA publishes a draft guidance with recommendations on lifecycle management and marketing submissions for AI-enabled medical devic...[ Price : $8.95]
FDA publishes a draft guidance intended to improve the representation of females in medical product clinical trials.[ Price : $8.95]
FDA requires safety labeling changes about Guillain-Barr syndrome risks for Pfizers Abrysvo (respiratory syncytial virus vaccine) ...[ Price : $8.95]
FDA publishes a draft guidance on developing drugs for optical imaging for three purposes.[ Price : $8.95]
FDA accepts for priority review a Dizal NDA for sunvozertinib, an oral EGFR inhibitor for treating locally advanced or metastatic ...[ Price : $8.95]
FDA posts a draft guidance entitled Considerations for Including Tissue Biopsies in Clinical Trials.[ Price : $8.95]
FDA releases a draft guidance entitled Considerations for the Use of Artificial Intelligence (AI) to Support Regulatory Decision-M...[ Price : $8.95]
Neumora Therapeutics says its Phase 3 KOASTAL-1 Study of navacaprant for treating major depressive disorder missed its primary end...