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Medical device manufacturers and their trade association say there are inconsistencies between FDAs unique device identification f...[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on over-the-counter drug labeling requirements to the Of...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted ...[ Price : $8.95]
FDA grants Dyax an orphan drug designation for DX-2930, a fully human monoclonal antibody inhibitor of plasma kallikrein for use i...[ Price : $8.95]
FDA clears a Ventana Medical Systems 510(k) for the Companion Algorithm Estrogen Receptor image analysis algorithm used with the V...[ Price : $8.95]
Attorney Arnold Friede says FDA should start a deliberate process to gain stakeholder input and develop a regulatory rationale for...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Pharmacy Compounding of Human Drug Products Under Section 503A of the Fede...