The “Answer Key” for Inspection Site Selections

In a posting on FDA.gov yesterday, September 5, 2018, FDA Commission Scott Gottlieb, M.D., further reinforced his goals of an open and transparent FDA by publishing FDA’s internal policy on inspection site selections (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm619435.htm).

The Center for Drug Evaluation and Research (CDER)  issued their internal policy Manual of Policies and Procedures (MAPP) 5014.1,