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CDRH 510(k) team leader Heather Rosecrans clarifies the use of Form 3654 Standards Data Report Form for 510(k)s, which has drawn s...[ Price : $8.95]
FDA approves Novartis Valturna (aliskiren and valsartan) tablets for treating high blood pressure.[ Price : $8.95]
FDA says it will give priority review to a Millennium sNDA for Velcade to treat patients with previously untreated multiple myelom...[ Price : $8.95]
FDA Webview editor Jim Dickinson analyzes commissioner Margaret Hamburgs daunting top priority rebuilding public trust and finds...[ Price : $8.95]
FDA approves Orchids ANDA for a generic version of Wyeths original intensive-care antibiotic, Zosyn[ Price : $8.95]
Arena says it will submit a December NDA to FDA for its weight management drug lorcaserin.[ Price : $8.95]
CDER operations research analyst Patrick Frey tells an industry audience that a still-developing CDER qualitative framework for be...[ Price : $8.95]
Federal Register Notice: FDA releases a guidance on the types of data and information obtained during IND studies that may be help...