FDA issues Olympus Medical Systems a Warning Letter after inspecting the firms Tokyo facility and documenting GMP deficiencies.
A federal judge approves a $25 million class action settlement involving Johnson & Johnsons Remicade (infliximab).
CDER posts its Office of Compliance Annual Report for fiscal year 2022.
Datascope/Getinge recalls Cardiosave Hybrid IABPs and Rescue IABPs because the coiled cable connecting the display and base on some units may fail, ca...
FDA publishes an updated question-and-answer guidance on the definition and regulation of medical foods.
Federal Register notice: FDA posts a final guidance entitled Definitions of Suspect Product and Illegitimate Product for Verification Obligations Unde...
Federal Register notice: FDA posts a draft guidance with information for sponsors who are developing certain local anesthetic drug products to produce...
Federal Register notice: FDA makes available a final guidance entitled The Use of Published Literature in Support of New Animal Drug Approvals.
