FDA Encourages Novel Switch Ideas, Though NSURE Remains Unsure
This article was originally published in The Tan Sheet
Executive Summary
Rx-to-OTC switch sponsors should not wait for FDA to act on NSURE before proposing innovative switch solutions, because reviewers are open to discussing ideas now, an agency official says. Some experts predict the new switch paradigm will not yield concrete regulatory changes, and are promoting other ways to expand OTC access.
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