Following this puts new work involving it at the top of your briefing, with a note saying why it is there. Links are taken from the source record, never inferred.
FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for an existing combination analgesic; this is a regulatory action, not a clinical evidence report.
FDA supplemental approval action establishing a REMS (Risk Evaluation and Mitigation Strategy) for an existing hydrocodone bitartrate and aspirin combination product; this record documents regulatory authorization but does not report clinical trial outcomes or efficacy data.