Four senators introduce bipartisan legislation to protect generic drug manufacturers from innovator drug lawsuits over skinny labeled generics.
FDA publishes an International Council for Harmonization draft M15 guidance on model-informed drug development principles.
FDA publishes a guidance with recommendations for participating in the agencys Advanced Manufacturing Technologies Designation Program.
FDA publishes the International Council on Harmonization E11A Pediatric Extrapolation guidance.
FDA publishes Annex 2 of the International Council on Harmonization Good Clinical Practice guidance.
FDA warns a Canadian Brands International facility about limiting and delaying an inspection that also identified CGMP violations.
FDA issues a complete response letter for Zealands glepaglutide intended to treat short bowel syndrome.
FDA warns a Viatris Mylan drug manufacturing facility in Pradesh, India, about CGMP violations involving quality and data issues.
