Friday, June 13, 2014

CDRH Offers Primer On Its Guidance Priority-Setting Process

CDRH Offers Primer On Its Guidance Priority-Setting Process-thegraysheet: CDRH annually prioritizes about one-third of the guidance documents it hopes to get out quickly and continuously analyzes its own progress. Nonetheless, limited resources and congressional input means that not all prioritized documents will be issued before the fiscal year ends, a device center policy official says. Phil Desjardin, associate director for policy at CDRH, discussed the center’s priority-setting process and, with other FDA managers, took feedback from industry and advocacy groups during a meeting held earlier this month at FDA’s headquarters in Silver Spring, Maryland.