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Adverse drug reactions

This article was originally published in The Tan Sheet

Executive Summary

FDA's Center for Drug Evaluation and Research announces in the Aug. 11 Federal Register the expected availability of $ 1.7 mil. in fiscal year 1994 for cooperative agreements to study serious and infrequent adverse effects of marketed drugs. "FDA expects to make five to six awards in the $ 300,000 to $ 400,000 range," the notice states. The agency also "seeks to fund a variety of databases which represent diverse patient populations and/or types of patient care settings." The databases "must be able to support the completion of one to two major studies per year of multiple drugs/multiple outcomes which are designed in collaboration with FDA." Applications should be received by Sept. 27.

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