FDA changing pre-approval inspection guidelines

In the coming months, new pre-approval inspection compliance guidelines will be implemented at CDER. For the most part, the undertaking is designed to refine the categories that would prompt a pre-approval investigation request and make them more "risk-based," in keeping with FDA's cGMPs for the 21st Century Initiative (1"The Pink Sheet," Aug. 27, 2007, p. 27). The revisions also are supposed to clarify the role of the various offices in the process...

In the coming months, new pre-approval inspection compliance guidelines will be implemented at CDER. For the most part, the undertaking is designed to refine the categories that would prompt a pre-approval investigation request and make them more "risk-based," in keeping with FDA's cGMPs for the 21st Century Initiative (¹ (Also see "A Closer Look: Supplement GMPs May Offer Insights For Drug GMPs" - Pink Sheet, 27 Aug, 2007.), p. 27). The revisions also are supposed to clarify the role of the various offices in the process....