Sept. 20, 2012 | Vol. 11 No. 185 | Full Issue in PDF Format
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The FDA is planning to reorganize its Office of Regulatory Affairs (ORA), including creating new offices and reorganizing others, as it takes steps to dissolve cumbersome domestic and international distinctions and to keep up with increasingly global operations.
The FDA is working with Boehringer Ingelheim to look into a possible increased risk of heart failure with Mirapex, a Parkinson’s disease and restless leg syndrome drug.
Janssen Biotech has submitted a BLA seeking approval of an IV formulation of Simponi to treat adults with moderate to severe rheumatoid arthritis (RA).
A procedural vote in the Senate Wednesday moves it closer to approving funding for the FDA through March 27.
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