FDA approves a Ferring Pharmaceuticals supplemental NDA for Zomacton (somatropin) for Injection 5 mg and 10 mg recombinant human growth hormone (GH), ...
A federal judge approves a plea bargain under which Aegerion pays $40.1 million to resolve all federal cases involving misbranding of its Juxtapid.
Masimo receives 510(k) clearance to sell its next-generation SedLine brain function monitoring device for use in anesthetized and sedated patients.
FDA warns Japans Daito Kasei Kogyo about CGMP issues at its Okayama API manufacturing facility.
FDA warns Chinas Hunan Norchem Pharmaceutical Co. about significant CGMP deviations in its manufacturing of active pharmaceutical ingredients.
Federal Register notice: FDA makes available a draft guidance entitled Qualified Infectious Disease Product Designation Questions and Answers.
Federal Register notice: FDA classifies the surgical smoke precipitator into Class 2 (special controls).
FDA says it continues to receive reports of serious heart problems and deaths with much higher than the recommended doses of the common over-the-count...