Cognitive Addresses FDA Keystone Guidance

Cognitive Solutions has announced that its thermal printers make an ideal solution for the generation of patient education leaflets that comply with the FDA’s Keystone guidance. “The education leaflets are a continuous document that is perforated and can be easily folded into a small 4-inch by 6-inch size,” says Raul Palacios, director of business development for Cognitive. And the forms, he explains, “are continuous, allowing for expansion and contraction of the document length, and keep the sheets of education information in order.”

Key requirements of the FDA’s Keystone guidance are that leaflets be printed in a minimum of 10-point type, use short line length, and have plenty of white space between sections in order to make them readable and useful.

Cognitive is using the XML version of First DataBank’s patient education monographs. And according to Nick Ratto, manager of the consumer drug information group at First DataBank, “their printouts of the patient education information meet or exceed the Keystone guidelines for formatting.”