Federal Register Notice: FDA seeks comments on an information collection associated with a guidance on labeling for outcome claims for drugs indicated to treat hypertension.
FDA commissioner Margaret Hamburg tells Senate appropriators that no furloughs are expected at the agency but there will be other sequester cuts of $209 million.
FDA is accused by a manufacturer of asserting “arbitrary and inconsistent” review standards in its proposed reclassification of three preamendment devices, giving one more favorable treatment than the other two.
University of Missouri researchers say the prescription drug propranolol, which is commonly used to treat high blood pressure, anxiety and panic, could also help improve the working memory abilities in those with autism.
FTC chair Edith Ramirez says the number of potentially anticompetitive pay-for-delay deals between branded and generic drug companies increased significantly in 2012 over 2011.
FDA approves a Phase 2 Neuralstem clinical trial at Emory University and an expanded site at University of Michigan using spinal cord-derived stem cells in treating Lou Gehring’s disease.
Santarus and Pharming Group NV file a BLA for Ruconest (recombinant human C1 esterase inhibitor) 50 U/kg, an investigational drug for treating acute angioedema attacks in patients with hereditary angioedema.
FDA says Baxter Healthcare’s Sigma Spectrum Infusion Pump with Master Drug Library is misbranded because the company did not obtain clearance for modifications to the device.