‘All The Information’ For OTC Switch DFLs Includes Important Warnings Used On Rx Drug Labels
OTC switches are more challenging for sponsors as concerns over label communication, drug interactions and consumers understanding increase, says FDA official Francis Becker. Rx label precautions and warnings must go on OTC labels, too.
You may also be interested in...
Harbor-UCLA Center for Clinical Pharmacology director Eric Brass says FDA should change DFL requirements, considering container labels as part of OTC labeling and reconsidering what information should be included on labels and threshold for consumer comprehension of labels.
"You need to demonstrate to the best of your ability that you can't get there with just the Drug Facts label," says ONDP Director Theresa Michele during presentation on the FDA office' work over the past year at Consumer Healthcare Products Association's annual regulations and science conference.
More information from "real world" experiences on how consumers make OTC selections may be needed to pull off a successful Rx-to-OTC switch of a statin