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FDA grants BioVie an orphan drug designation for BIV201 for treating ascites due to all causes except cancer.[ Price : $8.95]
GE Healthcare gains 510(k) clearance for MAGiC (Magnetic Resonance Image Compilation), which is a customized version of SyntheticM...[ Price : $8.95]
FDA posts a draft guidance on 510(k) Third Party Review Program that describes harmonization efforts, such as incorporating elemen...[ Price : $8.95]
FDA posts a one-page Form-483 from an inspection last month at troubled blood diagnostic firm Theranos.[ Price : $8.95]
Federal Register Notice: FDA releases a revised draft guidance: Health Document Submission Requirements for Tobacco Products.[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance entitled E17 General Principles for Planning and Design of Multi-Regional C...[ Price : $8.95]
Federal Register Notice: FDA plans a meeting of the Blood Products Advisory Committee 11/17 to discuss topics such as iron deficie...[ Price : $8.95]
Federal Register Notice: FDA plans a meeting of the Science Advisory Board to the National Center for Toxicological Research 11/1-...