Extra-Label Communication Could Foster Novel Switch NDAs – Industry Attorney
This article was originally published in The Tan Sheet
Executive Summary
FDA has several avenues to foster more novel Rx-to-OTC switches, including allowing extra-label communications beyond the packaging, similar to dispensing labeling used by a pharmacist, to be part of an approval.
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The developing Rx-to-nonprescription switch paradigm should exclude asthma and anaphylaxis drugs, advocates argue in a citizen petition. They say making inhalers available OTC contradicts the current standard for care.
Asthma Drug Petition Opposes OTC Approach, NSURE Paradigm
The developing Rx-to-nonprescription switch paradigm should exclude asthma and anaphylaxis drugs, advocates argue in a citizen petition. They say making inhalers available OTC contradicts the current standard for care.