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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.[ Price : $8.95]
FDA publishes Annex 2 of the International Council on Harmonization Good Clinical Practice guidance.[ Price : $8.95]
FDA warns a Canadian Brands International facility about limiting and delaying an inspection that also identified CGMP violations.[ Price : $8.95]
FDA issues a complete response letter for Zealands glepaglutide intended to treat short bowel syndrome.[ Price : $8.95]
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.