Archive for December 2009

DA, Health Organizations to Study Safety of Medications Taken During Pregnancy

A new research program called the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP) will fund research to study the effects of prescription medications used during pregnancy. The program is a collaboration among the U.S. Food and Drug Administration and researchers at the HMO Research Network Center for Education and Research in Therapeutics (CERT), Kaiser [...]



FDA’s positive response for Hexvix meantfor detection of bladder cancer

The Food and Drug Administration (FDA) has informed Photocure that the new drug application (NDA) for Hexvix for detection of non-invasive papillary bladder cancer may be approved pending approval of the PMA for the Karl Storz photodynamic diagnosis system and final agreements between Photocure and FDA on labeling, and post-marketing commitments. The photodynamic diagnosis system [...]



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