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FDA accepts for review a Daiichi Sankyo and AstraZeneca BLA for datopotamab deruxtecan (Dato-DXd) for treating certain adult patie...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Select Updates for the Medical Device User Fee Small Busine...[ Price : $8.95]
FDA publishes a new final guidance on assessing Covid-19-related symptoms in adults and adolescents who are subjects in clinical t...[ Price : $8.95]
Five stakeholders make suggestions for changes to an FDA draft guidance on using real-world evidence in medical device regulatory ...[ Price : $8.95]
CDRH director Jeffrey Shuren urges more medical device companies to join the Total Product Lifestyle Advisory Program.[ Price : $8.95]
Democratic leaders of the House Energy and Commerce Committee urge FDA to promptly issue the overdue draft guidance on drug and me...[ Price : $8.95]
FDA posts a Medtronic update on its NIM electromyogram endotracheal tubes, including actions to take in the event of airway obstru...[ Price : $8.95]
An FDA safety alert warns about the risks related to using smartwatches or smart rings that claim to measure blood glucose levels ...