Studies of Adverse Effects of Marketed Drugs; Availability of Grants (Cooperative Agreements); Request for Application

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The Food and Drug Administration (FDA), Center for Drug Evaluation and Research, is announcing $1.4 million for cooperative agreements to study adverse effects of drugs marketed in Canada, the United States and its territories, subject to the availability of Fiscal Year 1999 funds. This amount is consistent with the level of funding in the President's budget. FDA expects to make up to four awards for $300,000 per year for 3 years for general data bases and up to two awards for $100,000 per year for 3 years for special population data bases. The purpose of these agreements is to conduct drug safety analysis to the benefit of the public's health; respond expeditiously to urgent public safety concerns; provide a mechanism for collaborative pharmacoepidemiological research designed to test hypotheses, particularly those arising from suspected adverse reactions reported to FDA; and enable rapid access to multiple data sources to ensure public safety when necessary.