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Home » FDA Consolidates, Focuses MAPP Document on IND Clinical Holds
FDA Consolidates, Focuses MAPP Document on IND Clinical Holds
The FDA revised its Manual of Policies and Procedures document pertaining to issuing complete and partial clinical holds, including a reorganized background section that consolidates descriptions of IND clinical hold procedures, CFR citations and timelines for agency responses to sponsors. The new version also narrows its focus by omitting references to general IND review procedures included in the previous version that took effect in May 1998.
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