FDA posts a draft guidance entitled Pharmacogenomic Data Submissions that discusses the use of such data in drug development.
Federal Register notice: CDER announces the continuation of its Regulatory Project Management Site Tours and Regulatory Interaction Program.
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...
