FDA releases its latest batch of Warning Letters that includes Accelerated Analytical Laboratories, Aztex Enterprises and Kim Chemicals Private.
Three House members raise concerns about FDA oversight of a Bayer post-marketing study of its Essure birth control device that appears to be behind sc...
As part of the Trump Administrations national public health emergency declaration against opioid abuse, FDA commissioner Scott Gottlieb says the agenc...
Federal Register notice: FDA determines that EKR Therapeutics hypertension drug Cardene SR (nicardipine HCl) extended-release capsule (30 mg, 45 mg, a...
FDA clears three antimicrobial susceptibility tests for determining the appropriate usage of Melinta Therapeutics Baxdela (delafloxacin), a fluoroquin...
FDA approves a Janssen Pharmaceuticals supplemental NDA for a 10 mg once-daily dose of Xarelto (rivaroxaban) for reducing the continued risk for recur...
Federal Register notice: FDA announces a 12/18 public workshop to discuss methodological approaches for those intending to collect patient experience ...
FDA publishes an International Council For Harmonization guidance entitled E9 (R1) Statistical Principles for Clinical Trials: Addendum: Estimands and...