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Federal Register Notice: The Office of Management and Budget approves a collection on information on a guidance on adverse event r...[ Price : $8.95]
CDER issues a MAPP on using the Centers Network of Experts.[ Price : $8.95]
Novartis says it has agreed to pay $390 million to settle U.S. Justice Department charges that it paid illegal kickbacks to specia...[ Price : $8.95]
FDA clears a Mauna Kea Technologies 510(k) for Cellvizio, a multidisciplinary confocal laser endomicroscopy platform for use in ca...[ Price : $8.95]
FDA sends Pfizers Hospira drug unit a complete response letter for Retacrit, a biosimilar version of Amgens Epogen (epoetin alfa) ...[ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Product Development Under the Animal Rule to support approval of a drug or biolo...[ Price : $8.95]
Federal Register Notice: FDA releases a guidance entitled: Nonclinical Safety Evaluation of Reformulated Drug Products and Product...[ Price : $8.95]
FDA sends Sandoz a Warning Letter citing Indian manufacturing sites in Kalwe and Turbhe over GMP concerns.