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FDA warns a Viatris Mylan drug manufacturing facility in Pradesh, India, about CGMP violations involving quality and data issues.[ Price : $8.95]
FDA adds a liver injury Boxed Warning to labeling for Astellas menopause hot flash drug Veozah.[ Price : $8.95]
Lexicon stops development of its diabetes drug Zynquista that received an FDA complete response letter.[ Price : $8.95]
FDA warns Albuquerque, NM-based Sombra Cosmetics about CGMP violations in the manufacturing of finished drugs.[ Price : $8.95]
FDA approves Mesoblasts Ryoncil to treat some graft-versus-host disease pediatric patients.[ Price : $8.95]
FDA publishes an International Council for Harmonization draft M15 guidance on model-informed drug development principles.[ Price : $8.95]
FDA publishes a guidance with recommendations for participating in the agencys Advanced Manufacturing Technologies Designation Pro...[ Price : $8.95]
FDA publishes the International Council on Harmonization E11A Pediatric Extrapolation guidance.