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Patient activist group SANE Vax asks FDA to investigate the presence of HPV recombinant DNA that it says is contaminating Mercks G...[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on a guidance on formal dispute resolution to the Office...[ Price : $8.95]
FDA clears a Fujirebio Diagnostics 510(k) for the company's HE4 Test in an algorithm called ROMA and its use in assessing whether...[ Price : $8.95]
FDAs Philadelphia District Office warns Lehigh Valley Technologies about CGMP violations in its manufacturing of finished drug pro...[ Price : $8.95]
FDAs Philadelphia District Office warns Patient Transfer Systems of quality, MDR, and other violations in its manufacturing of Rap...[ Price : $8.95]
Discovery Labs files its response to a 2009 FDA complete response letter on its NDA for Surfaxin (lucinactant) for preventing resp...[ Price : $8.95]
CDER drug reviewers recommend not to approve a Janssen Pharmaceuticals NDA for its investigational drug Xarelto (rivaroxaban), whi...