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Some 30 GOP House members call on President Biden to take steps to alleviate a shortage of intravenous contrast agents.[ Price : $8.95]
FDA publishes the latest update for its list of off-patent, off-exclusivity drugs for which there are no approved generics.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Technical Performance Assessment of Quantitative Imaging in...[ Price : $8.95]
FDA releases the FDA-483 with six observations from an inspection at Phoenix, AZ-based Central Admixture Pharmacy Services.[ Price : $8.95]
FDA accepts for review a Merck supplemental BLA seeking approval for Keytruda (pembrolizumab) for the adjuvant treatment of patien...[ Price : $8.95]
Five stakeholders recommend changes and clarifications to an FDA draft guidance on CAR-T cell product development.[ Price : $8.95]
Six stakeholders provide comments to FDA on the agencys docket on human gene therapy products incorporating human genome editing.[ Price : $8.95]
CDER researchers describe the increasing use of artificial intelligence/machine learning in drug development regulatory submission...