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Postmarketing Study Status Report Out

04/24/2008

Federal Register Notice: FDA is reporting, as required by FDAMA, on the status of postmarketing study commitments made by applicants of approved drug and biological products. The annual progress report must include a description of the postmarketing study commitment, a schedule for completing the study commitment, and a characterization of the current status of the study commitment. It must also provide an explanation of the postmarketing study commitment's status by describing briefly the postmarketing study commitment's progress. To view this notice, click here.

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