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FDA accepts for review a Bristol Myers Squibb supplemental NDA for Camzyos (mavacamten) for an expanded indication to reduce the n...[ Price : $8.95]
FDA posts three FDA draft guidances that provide general recommendations for physicochemical and structural characterization tests...[ Price : $8.95]
A white paper commissioned by Georgetown University says changes are needed at FDA because its evidence standards have become dist...[ Price : $8.95]
FDA approves expanded labeling on Medtronics SelectSecure MRI SureScan Model 3830 cardiac lead for conduction system pacing.[ Price : $8.95]
Federal Register notice: FDA announces the Advancing Real-World Evidence (RWE) Program, which was agreed to under the recent user ...[ Price : $8.95]
PhRMA raises issues about the CDER Quality Management Maturity and Knowledge-Aided Assessment and Structured Application programs ...[ Price : $8.95]
Federal Register notice: FDA extends the comment period associated with a 9/30 notice on the proposed recommendations for the reau...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance #253 entitled Current Good Manufacturing Practice for Animal Cells, ...