FDA says it is lowering the minimum measles antibody potency specification for immune globulin products.
A Goldwater Institute investigative report faults FDA caution in approving new drugs, saying it stifles innovation and leads to unnecessary deaths.
FDA declines a BioElectronics 510(k) submission for its ActiPatch, seeking expanded over-the-counter indications for treating musculoskeletal pain.
FDA releases its latest batch of Warning Letters that include The Delano Co. and Mylan Pharmaceuticals.
Six drug company stakeholders ask FDA for changes to an agency draft guidance on post-approval changes to drug substances.
Hyman, Phelps & McNamara asks FDA not to approve a Zelnorm sNDA without substantial evidence of safety and efficacy under currently applicable standar...
Synaptive Medical recalls its BrightMatter Guide with SurfaceTrace Registration due to a software defect that could potentially result in serious or l...
FDA warns Mylan about CGMP violations at its Morgantown, WV, drug manufacturing facility.