FDA Statement - Published on December 3, 2018

The FDA published a statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to improve drug quality through vigilant oversight of data integrity and good manufacturing practice. The FDA released a new guidance document to advance best practices on data security to help manufacturers advance their own compliance policies. This new guidance is an update to the 2016 draft guidance, and covers the design, operation, and monitoring of systems and controls to maintain data integrity.