‘Heretical’ Rule Changes Could Make More Drugs Available OTC In US – Former NDAC Chair Brass
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.
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‘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.
Merck Silence On OTC Singulair Speaks Volumes On Switch Outlook
Merck’s silence on an OTC version of Singulair is a sign of the relatively “quiet” 2015 switch market despite the call for novel switches, particularly to treat chronic conditions, from FDA’s Nonprescription Drug Safe Use Regulatory Expansion Initiative.
FDA Advisors Say Greater Insight Needed On Self-Selection Of OTC Statins
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