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CDRH confirms that any device malfunction, regardless its severity, is a reportable event under FDAs Medical Device Reporting regu...[ Price : $8.95]
FDA issues a guidance to help manufacturers and researchers understand the minimum requirements the agency thinks must be met for ...[ Price : $8.95]
FDA issues a draft guidance giving CDERs current thinking on the appropriate classification of co-crystal solid state forms and th...[ Price : $8.95]
FDA grants orphan drug designation for Emergent BioSolutions TRU-016 to treat chronic lymphocytic leukemia.[ Price : $8.95]
FDA says Ben Venue has closed its Bedford, OH, manufacturing and distribution facility and is working with the agency to ease a sh...[ Price : $8.95]
Former FDA deputy commissioner Scott Gottlieb tells Congress that delays as long as several years in FDA approval of almost 3,000 ...[ Price : $8.95]
FDA clears a Covidien 510(k) for the SpiderFX for treating severely calcified lesions in arteries of the lower extremities.[ Price : $8.95]
Mylan says it and Famy Care Ltd. have been sued by Warner Chilcott after recentyly submitting an ANDA for a generic version of the...