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Federal Register notice: FDA makes available a draft guidance entitled Qualified Infectious Disease Product Designation Questions and Answers.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...
FDA issues two final guidances on acceptance and review criteria for 510(k)s and PMAs.
FDA revises its Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain.
FDA releases an FDA-483 with three observations from an inspection at Indias Shilpa Medicare Limited.