Aug. 1, 2012 | Vol. 11 No. 150 | Full Issue in PDF Format
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Drugmakers must dole out nearly $2 million in fees for drug applications requiring clinical data in fiscal 2013, while companies submitting applications without such data, or supplemental drug apps, will need to fork over half that amount.
Pfizer’s rheumatoid arthritis (RA) candidate tofacitinib will likely see its review date pushed back thanks to an FDA request for an additional data analysis.
A key Republican lawmaker is calling for more thorough government probes into the FDA’s monitoring of nine of its scientists as new information shows the agency may have broken more laws than congressional investigators previously believed.
The FDA has denied Regeneron Pharmaceuticals’ sBLA for Arcalyst for the prevention of gout flares and is requesting additional trial information.
Watson Laboratories has filed an ANDA to market generic versions of Sunovion Pharmaceuticals’ bronchospasm treatment Xopenex HFA prior to the patent’s expiration, sparking a lawsuit by Sunovion.
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