Regulatory Changes Key to FDA Success: Hamburg
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FDA commissioner Margaret Hamburg says the U.S. must make regulatory science a robust and respected discipline in the overall scie...
FDA Defends Vaccine Safety Questions in Lawsuit
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Faced with a lawsuit questioning FDAs approval procedure of the H1N1 vaccine, agency officials defend the vaccines safety saying t...
Mylan, Pfizer Reach Deal on Generic Vfend
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Mylan reaches agreement with Pfizer to market a generic Vfend starting in 2011.
Whistleblower Cases Dominate FD&C Act Prosecutions
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With more than 180 pharmaceutical fraud cases now under investigation by the Department of Justice, FD&C Act prosecutions are now ...
Senators Want Biosimilars Pathway in Reform Bill
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Sens. Hatch, Mikulski, Enzi, and Hagan say that a biosimilars approval pathway with 12 years of data exclusivity should be in any ...
