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FDA issues a draft guidance on using PBPK analyses for some biopharmaceutics applications.[ Price : $8.95]
Catalyst says it will appeal a Florida federal court ruling dismissing its case against FDA over orphan drug exclusivity for Firda...[ Price : $8.95]
Federal Register notice: FDA announces an amendment to a 10/22 Vaccines and Related Biological Products Advisory Committee meeting...[ Price : $8.95]
Federal Register notice: FDA announces a 10/6 public meeting entitled Patient-Focused Drug Development for Stimulant Use Disorder....[ Price : $8.95]
FDA launches its redesigned Sentinel Initiative Web site to increase organization and usability.[ Price : $8.95]
FDA says it has learned of three patients from one facility who were infected after undergoing cardiothoracic surgery involving th...[ Price : $8.95]
CBER director Peter Marks says vaccine makers already know data recommendations outlined in a proposed guidance currently on hold ...[ Price : $8.95]
CDER director Janet Woodcock says the Covid-19 pandemic has led to a further deterioration in the U.S. clinical trials system.