House Energy and Commerce Committee leaders send a letter to FDA commissioner Scott Gottlieb requesting a briefing on numerous recalls involving drugs...
FDA warns Samson Pharmaceuticals about CGMP violations in its production of finished pharmaceuticals.
FDA sends LC Medical Concepts a Warning Letter after an inspection of the firms Rochester, NY, medical device operations found GMP concerns with the m...
FDA warns Akorn about CGMP violations at its Decatur, IL, drug manufacturing facility.
FDA releases an FDA-483 with 13 observations from a 2018 inspection at Immunomedics, a drug substance intermediary manufacturing facility.
Attorney Adrienne Lenz says there are several provisions that should appeal to industry in an FDA final guidance on least burdensome approaches.
FDA issues a draft guidance seeking comment on a proposed CDER program issue a list of recognized voluntary consensus standards related to drug qualit...
Federal Register notice: FDA issues an Emergency Use Authorization (EUA) for a Chembio Diagnostic Systems in vitro diagnostic device for detecting Ebo...