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Federal Register Notice: FDA releases a revised draft guidance: Bioequivalence Recommendations for Paliperidone Palmitate.[ Price : $8.95]
Outspoken FDA reviewer Thomas Marciniak takes to the BMJ (formerly the British Medical Journal) to detail how the clinical trial p...[ Price : $8.95]
FDA associate commissioner for external affairs Virginia Cox leaves the agency next month to pursue other opportunities.[ 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Federal Register Notice: FDA releases a draft guidance: Pharmacy Compounding of Human Drug Products Under Section 503A of the Fede...