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Federal Register Notice: FDA releases additional product-specific guidance on the design of bioquivalence studies to support ANDAs...[ Price : $8.95]
FDA commissioner Margaret Hamburg says that that if academia, industry, government scientists and regulators could come together m...[ Price : $8.95]
Three months ahead of its user fee review date, FDA approves an Ariad Pharmaceuticals NDA for Iclusig to treat adults with two for...[ Price : $8.95]
FDA approves Human Genome Sciences raxibacumab injection to treat inhalational anthrax.[ Price : $8.95]
Representatives from FDA, the Centers for Medicare and Medicaid Services and Department of Justice discuss policy considerations a...[ Price : $8.95]
FDA accepts an Actelion NDA for Opsumit (macitentan), indicated for treating patients with pulmonary arterial hypertension.[ Price : $8.95]
Bayer HealthCare submits an NDA for radium Ra 223 dichloride, an investigational compound for treating castration-resistant prosta...[ Price : $8.95]
FDA denies a Jazz Pharmaceutical citizen petition that asked the agency to not accept any ANDA referencing its Xyrem that did not ...