[ Price : $8.95]
FDA says Teva has recalled one lot of its topotecan injection following a complaint about foreign particles in one vial.[ Price : $8.95]
FDA issues a guidance with recommendations on an alternate electronic format for some submissions to CDER and CBER.[ Price : $8.95]
ChemoCentryx files an amendment to its NDA for avacopan for treating anti-neutrophil cytoplasmic autoantibody-associated vasculiti...[ Price : $8.95]
FDA warns Lupin of CGMP violations at its Novel Laboratories drug manufacturing facility in New Jersey.[ Price : $8.95]
FDA issues a draft guidance on assessing adhesion for topical and transdermal systems submitted in NDAs and sNDAs.[ Price : $8.95]
FDA Webview posts the Federal Register notices released during our holiday week (6/28 to 7/2).[ Price : $8.95]
FDA posts a final guidance entitled Unique Device Identification System: Form and Content of the Unique Device Identifier.[ Price : $8.95]
FDA sends Provention Bio a complete response letter on its BLA for teplizumab and its use for delaying clinical Type 1 diabetes in...