[ 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 warns Becton Dickinson about multiple violations at its San Diego facility that manufactures the Pyxis Medication Management S...[ Price : $8.95]
FDA publishes a draft guidance on defining, identifying, and reporting protocol deviations in clinical investigations.[ Price : $8.95]
FDA says a Boston Scientific recall updating instructions for two cryoablation balloon catheters is Class 1.[ Price : $8.95]
FDA warns Akorn Formulations in Hyderabad, Telangana, India, about CGMP violations in its production of over-the-counter drugs for...[ Price : $8.95]
CDER senior advisor for clinical science Bob Temple retires, and FDA principal deputy commissioner Namandj Bumpus leaves the agenc...[ Price : $8.95]
Xbrane Biopharma refiles a BLA for its investigational ranibizumab, a biosimilar copy of Genentechs age-related macular degenerati...