Sponsors interested in pursuing innovative Rx-to-OTC switches should open a dialogue with FDA now, rather than wait until the agency further develops its nascent new paradigm for expanding the availability of nonprescription drugs, an FDA official said.
FDA Encourages Novel Switch Ideas, Though NSURE Remains Unsure
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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