HHS approves an influenza vaccines manufacturing facility in Bryan-College Station, TX as part of a partnership between GlaxoSmithKline and Texas A&M University and the Center for Innovation in Advanced Development and Manufacturing.
Federal Register Notice: FDA submits a proposed collection to the Office of Management and Budget on food labeling and notification procedures for statements on dietary supplements.
FDA denies a Warner Chilcott petition asking that it change its bioequivalence recommendations for generic versions of orally-ingested modified-release mesalamine drugs.
An Institute of Medicine workshop examines human genome sequencing and the identification of links between specific genetic variants and diseases and their potential to direct patient.
FDA grants Acceleron Pharma two orphan drug designations for ACE-536 for treating beta-thalassemia and myelodysplastic syndromes, two rare blood disorders characterized by severe and chronic anemia.
FDA posts a Class 1 recall notice on Spacelabs’ BleaseSirius Anesthesia Workstation due to a defect in the device’s CAS I/II Absorbers that may cause a condition leading to an increase in the carbon dioxide concentration.