USFDA received 25 percent more reports of adverse drug events in 2008 compared with 2007,  according to a new QuarterWatch report from the Institute for Safe Medication Practices. In 2008, the FDA received reports of nearly 100,800 cases of serious injury related to drug use...compared with 80,600 in 2007,  the largest over a one-year period since the FDA began collecting data in 1998.
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Here is an update on drug product research from my reading –

On November 5, 2009, the U.S. Food and Drug Administration granted approval to romidepsin for injection (ISTODAX, Gloucester Pharmaceuticals Inc.) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.

The efficacy and safety of romidepsin were evaluated in two single-arm, multicenter, open label trials.  Efficacy was assessed in 167 patients with CTCL treated in the United States, Europe, and Australia. 

The recommended dose and schedule of romidepsin is 14 mg/m2 intravenously over 4 hours on days 1, 8 and 15 of a 28-day cycle. 

For further reading please visit : http://www.pharm-education.com/2009/11/update-on-romidepsin-formulation.html
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