FDAnews Drug Daily Bulletin

SEVERAL GUIDANCES WITHDRAWN AS INCONSISTENT WITH NEW CGMP INITIATIVE

June 7, 2006
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The FDA, in a notice published in the Federal Register, announced its plans to withdraw and revise seven guidances as inconsistent with its pharmaceutical current good manufacturing practices (cGMP) initiative.

The agency announced its Pharmaceutical Current Good Manufacturing Practices for the 21st Century on Aug. 21, 2002. The initiative is meant to "enhance the cGMP, to focus our resources and regulatory attention on those aspects of manufacturing that pose the greatest risk to the quality of the product, to ensure that our work does not impede innovation in manufacturing, and to promote consistency in our regulatory approach," the agency says.

The FDA is continuing to review its guidance and will withdraw and revise other guidance documents that are inconsistent with the initiative, the notice adds. The agency is also planning new guidances to support its initiative.

The notice is available at: http://www.fda.gov/OHRMS/DOCKETS/98fr/cd062.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/cd062.pdf).