US FDA’s Proposed ACNU OTC ‘Failure’ Reports Requirement: Asking Too Much, Or Too Little?

Periodic summaries FDA is considering are “most effective method to track and report relevant concerns,” but “failure” as outlined in proposed rule is too broad, says CHPA. Digital care delivery firm Amwell says FDA should ask ACNU OTC marketers for some individual adverse event reports in addition to summaries.

The views an industry trade group and a medical technology firm have on adverse event reporting requirements neeeded in the proposed “additional condition for nonprescription use” rule in the US track in some areas but diverge on an important point.

The Consumer Healthcare Products Association supports an alternative reporting mechanism the Food and Drug Administration is considering, which would require...