Phase IV Status Report: Fewer Open Studies, But More Overdue Reports
Executive Summary
The pharmaceutical industry had 67% fewer drugs and biologics with open Phase IV commitments in fiscal year 2004 than the previous year, FDA's postmarketing database shows
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FDA May Seek More Authority To Require Post-Marketing Safety Studies
FDA may consider asking for more authority to compel companies to undertake post-marketing drug safety studies after examining manufacturers' compliance with existing Phase IV commitments
FDA May Seek More Authority To Require Post-Marketing Safety Studies
FDA may consider asking for more authority to compel companies to undertake post-marketing drug safety studies after examining manufacturers' compliance with existing Phase IV commitments
Post-Marketing Safety Studies Could Be Funded By User Fees, Cmte. Suggests
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