Blog: Focus On Regulation | 12 December 2018

FDA Finalizes Data Integrity Guidance, With Some Noteworthy Changes

Earlier today, FDA published its finalized Data Integrity Guidance. The Final Guidance is entitled “Data Integrity and Compliance With Drug CGMP: Questions and Answers,” and updates the agency’s April 2016 Draft Guidance covering the design, operation, and monitoring of systems and controls to maintain data integrity to comply with current good manufacturing practice (cGMP) for drugs. The Final Guidance says that in recent years, FDA has “increasingly observed cGMP violations involving data integrity” during inspections, and in a statement announcing the guidance, FDA Commissioner Scott Gottlieb, M.D. similarly expressed concern over data integrity violations that have been the result of both deceptive practices and inadequate controls and oversight to ensure reliable and accurate data.

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